76 Regulatory Affairs jobs in Ireland

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Join us The GoFundMe team is searching for our next Regulatory Affairs Analyst to help interpret regulatory changes and ensure our products, policies, and communications comply with all relevant laws and standards. This includes preparing reports, documentation, and responses to regulatory agencies while collaborating across teams to integrate compliance into product planning.

Already part of our team? We ask that internal candidates apply via the internal job board to ensure your application is reviewed appropriately.

The Job

• Conduct complex investigations into potential financial crimes, including fraud, money laundering, and sanctions compliance, using advanced data analysis and research methodologies.
• Lead comprehensive investigations, gathering evidence, analyzing user and transaction behavior, and working cross-functionally to mitigate risks.
• Analyze large, complex datasets to detect suspicious activity, leveraging advanced analytical tools and techniques.
• Provide legislative analysis to ensure compliance with emerging laws and regulations, interpreting their impact on financial crime prevention strategies, donation volume, and customer experience.
• Prepare detailed investigative and legislative reports for senior management, law enforcement, and regulatory authorities, clearly documenting findings and recommendations.
• Collaborate with internal teams (compliance, legal, risk) and external law enforcement or regulatory bodies to manage financial crime cases.
• Stay informed on new financial crime trends and legislative changes, contributing to the improvement of policies and procedures for fraud detection and prevention.

You

• 1-2 years of experience in financial crime investigations, data analysis, or compliance.
• Bachelor's degree in Data Science, Economics, Finance, Criminal Justice, Mathematics, or a related field.
• Strong proficiency in data analysis tools (e.g. Looker, SQL, Excel) and transaction monitoring systems.
• Knowledge of financial crime laws and regulations, including AML, KYC, and sanctions compliance, and experience with legislative analysis.
• Ability to synthesize complex data and legal information into actionable insights.
• Excellent written and verbal communication skills, with the ability to present findings clearly to both technical and non-technical audiences.
• Fluency in English and one of either: Spanish, French, German, or Italian
• Professional certifications such as CAMS (Certified Anti-Money Laundering Specialist) or equivalent are a plus.
• Strong ethical standards and discretion when handling sensitive information.

Preferred

• Experience liaising with law enforcement or regulatory agencies on financial crime investigations.
• Familiarity with machine learning or AI-driven tools for fraud detection and their attendant regulations.
• Uncommon ability to anticipate, adapt, and respond to sensitive and evolving situations while balancing numerous, often competing, priorities.

Why you'll love it here

• Make an Impact: Be part of a mission-driven organization making a positive difference in millions of lives every year.
• Innovative Environment: Work with a diverse, passionate, and talented team in a fast-paced, forward-thinking atmosphere.
• Collaborative Team: Join a fun and collaborative team that works hard and celebrates success together.
• Competitive Benefits: Enjoy competitive pay and comprehensive healthcare benefits.
• Holistic Support: Enjoy financial assistance for things like hybrid work, family planning, along with generous parental leave, flexible time-off policies, and mental health and wellness resources to support your overall well-being.
• Growth Opportunities: Participate in learning, development, and recognition programs to help you thrive and grow.
• Commitment to DEI: Contribute to diversity, equity, and inclusion through ongoing initiatives and employee resource groups.
• Community Engagement: Make a difference through our volunteering and Gives Back programs.

We live by our core values:
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earn trust every day
,
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. Be a part of something bigger with us

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About PerfuzePerfuze is a growth stage medical device company, based in Galway, dedicated to improving the quality of life for stroke patients. Perfuze is developing innovative catheter-based technology to remove clots from the brain following Acute Ischemic Stroke. At Perfuze, our mission is to halve the number of patients who suffer disability post stroke treatment. We want to accelerate and advance our ability to create significant innovations, but we will only succeed with the right people on our team.

Perfuze is based in Dangan on the west side of Galway City. Our Cultureo An inclusive work environment, where all the employees are valued, supported, and encouraged. o All employees have a seat at the table and have influence. o A collaborative teamwork environment where learning is constant, and performance is rewarded.o The opportunity to be at the forefront of a technology that can positively impact the treatment of one of the world's most devastating diseases.

Regulatory Affairs ManagerThe Regulatory Affairs Manager is responsible for regulatory compliance activities at Perfuze. The position requires a high level of innovative thought, problem-solving skills and structured time and task management.Responsibilities o Define regulatory strategy for new products and oversee all regulatory activities required for sustaining existing product approvals/clearances.o Oversee all regulatory filings, including 510(k) and CE mark submissions, associated regulatory interactions, and product registrations.o Develop and maintain relationships with regulatory agencies, including FDA and our Notified Body. o Monitor changes to applicable regulations and incorporate these into the regulatory strategy for Perfuze products that is consistent with company goals. o Work with Quality Assurance to ensure all post-market surveillance and vigilance activities are performed according to applicable European and US regulations.o Oversee regulatory review process for advertising and promotional material.o Identify and manage resources required for effective functioning of regulatory process.

o Provide strategic guidance to Perfuze team on regulatory issues.Requirementso Degree in Engineering, Science or health-related discipline.o 10+ years' experience in the medical device industry, preferably 3 of which were in a management role. o Deep understanding of US and EU regulatory requirements for medical devices. o Strong self-management and organisational skills, ability to manage workload, ability to set and adjust priorities to align with company goals.o Proven ability to manage and coach others effectively. o Good interpersonal & communication skills essential.o Excellent communication and comprehension skills.o Experience working in an SME environment, preferably in a medtech start-up.o A hands-on mindset.If interested, please submit your CV and a letter outlining why you are the right person for the role

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

Medtronic

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Our Purpose

At our Regulatory Affairs department in Medtronic, plc, based in Galway our mission is to develop innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment to benefit the patients we serve. Regulatory Affairs is a key function within the business and this role is supporting the Structural Heart (SH) business.

Come for a job, stay for a career

A Day in The Life Of:

• Directs or performs coordination and preparation of document packages for regulatory submissions.
• Teams with other Regulatory Affairs Specialists and international regulatory specialists to provide regulatory support for changes to existing products.
• Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Supports change control activities to support global approval and implementation of product and process changes.
• Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
• Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
• May direct interaction with regulatory agencies on defined matters.
• Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
• Monitors and improves tracking/control systems.
• Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.

Key Skills & Experience

• We are looking for a person qualified to Level 8 Science or Engineering honours bachelor's degree and minimum of 2 years of relevant experience.
• Regulatory Affairs qualification is desirable, but not mandatory.
• Regulatory experience in Medical Devices and/or Pharmaceuticals is required.
• You are a dynamic team player and can work effectively and proactively on activities both individually and in teams.
• You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
• You collaborate with others and create alignment with team members.
• You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behaviour.
• Ability to work independently and under general direction only.
• Strong proficiency skills with I.T systems and data collection.

Medtronic offer a competitive salary and flexible Benefits Package

#IJ

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

I am partnering with
Abbott Rapid Diagnostics
to hire a
Regulatory Affairs Specialist II
on an initial on
12 month contract
to
support an exciting new project.

Working Model: Remote

Overview

For the Abbott Rapid Diagnostics Infectious Disease Business Unit, we are looking for a talented and dynamic Regulatory professional to coordinate and manage all related RA activities for the Abbott portfolio in a designated list of countries as part of the EU RA regional team.

Responsibilites

· Support and develop regulatory submission plan for the region in terms of IVDR transition project in collaboration with Global RA IVDR project team, Legal manufacturing sites, supply chain, marketing, commercial and in country Distributors.

· Assist to manage applicable change control projects for regional team by working closely with relevant manufacturing sites and other functions to obtain all necessary dossiers to support product registration, or amendment to existing product certificates and maintain database with risk escalation if necessary.

· Track applicable regulatory milestones in internal Regulatory database per defined Key Performance Indicators.

· Represent RA and/or region at relevant meetings such as IVDR meetings or change control meetings.

· Provide secondary support as backup towards local Regulatory Affairs matters as applicable.

· Support Abbott strategic Quality and Regulatory Affairs Goals and objectives.

· Monitor developing regulations and gather regulatory intelligence that may be relevant to the business.

· Perform ad hoc duties as deemed necessary for the position and business.

Qualifications

· BSc or equivalent.

· A minimum of 2 years' experience in Regulatory Affairs, preferably in Medical Devices, ideally in IVDs.

Competencies and Attributes

· Demonstrable working knowledge of the pharmaceutical industry in the regions they will support.

· Demonstrated capacity in project management.

· Ability to navigate in a cross-functional environment.

· Knowledge of the regulatory environment in European Union (MDR/IVDR, local legislation, industry standards and guidance).

· Excellent written and oral communication skills in English.

· Attention to detail.

· Strong interpersonal skills.

· Highest levels of integrity and diplomacy.

· Capacity to maintain the highest levels of confidentiality internally and externally.

Position Title:
Regulatory Affairs Specialist

(This position will not involve people management; therefore, the title is "Specialist")

Reports To:
General Manager of ARKRAY IRELAND LIMITED

Role Summary

ARKRAY is looking for an experienced Regulatory Affairs Specialist who can act as the Authorized Representative regarding the Person Responsible for Regulatory Compliance defined in the European IVDR. When joining ARKRAY as its regulatory member in Europe, you will function independently as the key contact for regulatory issues within Europe, but will also be working closely with the Quality Team in Ireland, Japan Headquarters, and its other overseas members to share knowledge and expertise in support of team activities.

Duties and Responsibilities

PRRC

• Ensure the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
• Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up to date.
• Ensure the post-market surveillance and vigilance reporting obligations are complied with in accordance with IVDR and cooperate with those involved.

Regulatory Affairs

• Provide guidance and interpretation of IVDR requirements for the design and development of new products. Recommend and implement compliance strategies for existing, new, and proposed products or product changes.
• Act as the main point of contact between ARKRAY companies and Notified Bodies/Competent Authorities for new product development and changes to existing products.
• a) Work closely with the Regulatory Affairs and Quality Management teams in Japan to establish robust regulatory/quality systems that comply with IVDR.
• b) Work closely with the Design and Development teams in Japan to ensure the implementation of requirements from IVDR.
• c) Assist and coordinate product performance evaluations or clinical trials in Europe.
• d) Review and approve technical documents to assemble an IVDR-compliant technical file and keep them up to date.

Knowledge and Skills

Required/Preferred

• Four years of professional experience in European regulatory affairs or quality systems management related to medical devices.
• English business level or above.
• Experience in IVDR for Class A, B, and C products, such as Laboratory and Point of Care IVD products.
• Experience with ISO, GMP/QSR, and other regulatory issues related to IVD medical products.
• MDR regulatory and/or Quality System Management experience preferred.

Working Location

ARKRAY IRELAND LIMITED.

First Floor, , Sir John Rogerson's Quay, Dublin 2, Dublin, D02 Kv60, Ireland

We are currently working with a client in the medical device sector who is seeking an experienced
Regulatory Affairs Manager
to join their team in Galway. This is a fantastic opportunity to play a key role in shaping regulatory strategy and ensuring successful product approvals for innovative medical technologies.

The Role

As
Regulatory Affairs Manager
, you will be responsible for driving regulatory compliance activities, leading submissions, and building strong relationships with regulatory bodies. The role requires a mix of regulatory expertise, leadership, and a hands-on approach.

Key Responsibilities

• Define and execute regulatory strategy for new and existing products.
• Lead regulatory filings including 510(k), CE mark submissions, product registrations, and regulatory interactions.
• Build and maintain strong relationships with the FDA, Notified Bodies, and other regulatory agencies.
• Monitor regulatory changes and adapt company strategy accordingly.
• Collaborate with Quality Assurance on post-market surveillance and vigilance activities in Europe and the US.
• Review and approve advertising and promotional materials from a regulatory standpoint.
• Provide strategic regulatory guidance to the wider leadership team.
• Manage and develop resources within the regulatory function.

What We're Looking For

• Degree in Engineering, Science, or a health-related discipline.
• 10+ years' experience in the medical device industry, including at least 3 years in a management role.
• Strong knowledge of US and EU regulatory requirements (510(k), CE Mark, FDA, Notified Body interactions).
• Proven leadership, coaching, and mentoring skills.
• Excellent organisational, problem-solving, and prioritisation abilities.
• Strong communication and interpersonal skills.
• Experience in an SME or start-up environment is an advantage.
• A proactive, hands-on mindset.

Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

The Regulatory Affairs Specialist for Beckman Coulter Diagnostics is responsible for ensuring that the quality systems aspects such as CAPA management, global procedure review and participation in the cross-site Global Regulatory Affairs initiatives in addition to product registration, IVDR document maintenance and minor/moderate design change management for the AU Chemistry Product line.

This position is part of the Quality and Regulatory Affairs Department located in Beckman Coulter Ireland Inc., Lismeehan, O'Callaghan's Mills, Co. Clare, Ireland and is an on-site position. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Regulatory Affairs team and report to the Senior Regulatory Affairs Manager, be responsible for providing regulatory support to local regulatory team on site, Beckman Coulter customers and Beckman Coulter's commercial regulatory teams globally. If you thrive in a fast paced, challenging and supporting role in a company that is focused on sustainability and want to work to build a world-class Quality and Regulatory Affairs organization—read on.

This role is eligible for flexible work arrangements
In This Role, You Will Have The Opportunity To

• Prepare and maintain technical files in compliance with IVD Directive and IVD regulation as applicable for the EU.
• Act as RA representative on Design Change projects which includes the development and implementation of registration strategies for new product launches.
• Review, preparation and compilation of documentation required for global regulatory submissions.
• Support change management and perform RA support for minor and moderate design changes for the AU product line.
• Support Global RA tasks/projects, which may include supporting RA colleagues outside of the Co. Clare site
• Control distribution of product from regulatory perspective through regulatory stop ship program.
• Be able to work in a busy environment

The Essential Requirements Of The Job Include

• Qualified to a minimum of B.Sc. Level in a Science related field with a minimum of 3 years' experience in a QA or RA role within a manufacturing facility.
• Excellent written and communication skills

It would be a plus if you also possess previous experience in:

• Manage change effectively in order to better serve internal customers, external customers and legislative demands, in a busy environment, with demonstrated ability to multi-task
• Understanding of the ISO13485, ISO9001, CMDR, MDLW, ANVISA, TGA, IVDD, IVDR and FDA (including China) regulation requirements.

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit

CMC Consultant

職務内容:

• プロジェクトリーダーの指示のもと、新薬開発段階での開発戦略及びCMC薬事戦略策定から製造販売承認申請及び承認取得後の製品の変更管理に関わるCMC薬事業務全般。また、クライントと協議、交渉を行う。

業務内容

• 薬剤開発におけるCMC関連の既存成績並びに情報の分析並びに評価

• 日本での臨床開発計画及び薬事申請のためのCMC薬事戦略の策定。

• 製造販売承認申請資料(新規申請、一変申請及び軽微変更届)の作成及び申請。
• PMDA相談資料作成及び規制当局との照会事項対応。
• 申請後の照会事項対応及びPMDAとの対応支援を行い、製造販売承認を取得。
• 医薬品原薬等登録原簿(MF)及び外国製造業者認定(FMA)手続きの支援
• GMP適合性調査サポート
• カルタヘナ法に係る申請手続きの支援
• 医薬品原薬等登録原簿の国内管理人業務(変更管理における薬事評価を含む)
• 様々な薬事コンサルティング

条件:

• 製薬会社における医薬品開発(もしくはCROでの勤務)におけるCMC薬事経験3年以上
• 製薬会社における製剤開発又は分析研究等のCMC研究経験、または製造施設での品質管理(製造管理、分析・試験)等の経験
• 製造販売承認申請書作成、CTD作成、医薬品原薬等登録原簿の作成などの経験
• 生物製剤に関するCMC経験者なら、尚可
• 最終学歴: 大学卒(薬学もしくはその他の自然科学分野の専攻

Clinical Consultant

職務内容:

・プロジェクトリーダーの指示のもと、Gap分析レポート作成、開発戦略策定、PMDA相談資料、申請資料等の作成を行う

・必要に応じて、クライントと協働し、規制当局との交渉を実施する

・日本国内における医薬品開発ならびに薬事申請を、社内の業務手順を遵守し、高い品質をもって推進する

業務内容

・薬剤開発における既存成績並びに情報の分析並びに評価

・日本での臨床開発計画をクライントと協働し、策定する

・日本の薬事規制に関する社内外からの問い合わせに対し回答及び助言を行う

・国内治験管理人として臨床試験を監督し、適宜助言を行う

・新医薬品の製造販売承認申請に関し、CTD資料作成(添付文書案等のModule1関連の資料作成を含む)を行い、クライアントと協働して、申請後の照会事項対応及びPMDAとの対応支援を実施し、製造販売承認を取得する

・クライントと協働して、PMDA対面助言を実施、規制当局との折衝を行なう

・薬事規制の調査及びコンサルテーション

必須条件:

・製薬会社もしくはCROでのPMDA対面助言の実施、規制当局との折衝の経験

・治験届出業務、承認申請及び添付文書作成等の経験

・バイオシミラー、医療機器、後発品開発申請、再生医療等製品の経験も、考慮する

・最終学歴: 大学卒以上(薬学もしくはその他の自然科学分野の専攻)

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Main objective of Role

• Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards and corporate requirements;
• Manage international regulatory submissions according to company strategy and ensure registration deadlines are met;
• Respond to Health Authorities' queries and deficiencies in a timely manner;
• Liaise with other departments to support the timely introduction of new products into markets;
• Work as part of a team dealing with global registrations and providing regulatory support to all operational departments within the company;
• Maintain assigned products' Marketing Authorisations via submission of the appropriate variations and renewals in a timely manner;
• Communicate Health Authority approvals/final decisions to the relevant departments;
• Build departmental awareness of local regulatory requirements in global markets;
• Assess the impact on existing files when new regulatory requirements are issued;
• Archive the registration documentation according to internal standards; introduce and regularly update the internal RA database
• Perform assigned tasks to the highest standard and in accordance with established internal timelines and guidelines.

Job Duties
DOSSIER MANAGEMENT
Tasks related to the RA Plan

• Assist in the development of regulatory strategy as well as monitoring the impact of the changing regulatory environment on submission strategies.
• Proactively inform the RA Manager and other involved functions regarding all identified risks related to the planned MAA.
• Submit Marketing Authorisation Applications (MAA) to Health Authorities according to the registration plan and company's registration strategy.
• Obtain scientific advice from Health Authorities by liaising with the Health Authorities and preparation of all the required documents.
• Attend regulatory strategy or submission meetings with Health Authorities.
• Contribute to reviewing regulatory aspects of in-licensing contracts and agreements.

Compilation of registration dossiers for identified markets

• Review of regulatory submissions/MAAs for accuracy, completeness and compliance with EU or relevant Health Authority regulations and relevant guidelines; ensure that all specific national requirements are met.
• Compile the hard copy and/or eCTD of the registration dossier (depending on specific in-country registration requirements.
• Identify and then obtain any deficient information in order to complete the compilation within the allocated time frame.
• Raise all identified risks related to the quality of the dossier in order to meet submission deadlines, without compromising the quality of the submission.
• Auditing the licensor's registration dossier vs. EU guidelines and, if relevant, specific national requirements as part of the in-licensing process in order to evaluate and assess its acceptability and identify all future possible major Health Authority deficiencies.

Submission and registration process

• Prepare, as per internal process, the data needed to make all required registration fees in a timely manner.
• Dispatch the documentation in the appropriate manner in order to deliver it to the relevant Health Authority or local Regulatory Service Provider or local Marketing Authorisation Holder (MAH); ensure the delivery is confirmed.
• Answer all queries received from Health Authorities during the validation phase of registration.
• Ensure all internal RA database are updated with any new specific national requirements.
• Co-ordinate and communicate trade name rejection.
• Address all deficiencies identified by the Health Authority in an appropriate manner within the required timelines. During the Response to Questions preparation liaise closely with internal/external contacts, relevant departmental staff and Health Authorities to ensure efficient and timely product registration.
• Communicate any change in status for assigned tasks. Raise all identified risks related to the deficiencies from Health Authorities which might cause negative decision of procedure or delays in timelines.
• Monitor planned approval timelines and if necessary intervene in order to facilitate approval and minimise registration delays.
• Organise national translations in efficient and organised manner in order to meet strict registration timelines during national phase of registration (EU: MRP, DCP, CP, Work-sharing procedure).
• Co-ordinate national phase with the Health Authority, Artwork Department, PV Department, local affiliate or local Regulatory Service Providers/local MAH to resolve any issues related to national translation of product information in order to obtain Marketing Authorisation.
• Review Marketing Authorisation/Registration Certificates for errors and ensure successful correction.
• Update and archive registration documentation according to the internal standards.
• Communicate MA approvals to all relevant personnel and update the relevant entries in all RA databases.
• Organise the handover of required data from dossier and registration process to allow efficient preparation for the first launch and marketing

Maintain the assigned products' marketing authorisations in Markets

• Provide regulatory input to product lifecycle planning, including building of renewal plans, assessing the risk related to 'sunset clause' provision
• Provide regulatory assessment and strategy and regulatory impact assessment for change controls.
• Analyse the input of cumulative product changes to current product submissions.
• Impact assessment on existing files when new requirements are issued.
• Review, prepare and compile the registration documentation required to maintain MAs, for example variations (required internally or requested by Health Authorities), any supplements to dossiers, notification, renewals.
• Inform other relevant functions about all relevant submissions e.g. variations, renewal and their predicted approval time.
• Compile the regulatory component of annual product quality review (PQR) and PSUR/PBER.

Projects and team working

• Work as part of a team dealing with global registrations and provide regulatory support (guidance and strategy) to multi-disciplinary team and all operational departments within the company.
• Liaise with the Global IP and (if required) other Hubs with respect to Global dossiers and related projects in order to ensure required documentation is available on time, fully complete and accurate.
• Report monthly on status of assigned projects.
• Acting as a mentor and supervisor to less experienced staff.
• If necessary substitute and/or give support to the departmental colleagues in order to ensure all tasks assigned to the team are timely performed.
• Share and exchange knowledge gained from everyday work and trainings with departmental staff.

Regulatory Good Practice

• Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
• Ensure that any regulatory changes communicated to the pharmaceutical industry by Regulatory Authorities are raised to the RA Manager in order that they are implemented without delay within the relevant department.
• Investigate and maintain regulatory knowledge within the department.
• Provide regular training within the department regarding specific regulatory affairs topics assigned by the departmental manager and communicate this topic to the RA Department.
• Contribute in development of new regulatory policies, processes, rules of cooperation and SOPs and train key personnel on them.

PERSONAL DEVELOPMENT PLANS
Learning and growth

• Information is gathered about development needs
• Training and development as discussed with manager.
• Learning solutions are identified, proposed and implemented according to ongoing personal and team development plans.
• Best practice is encouraged to ensure expertise. Improving skills and multiskilling are co-ordinated in line with staff development.
• Any other duties as assigned by your Manager

Education & Job Related Work Experience Required

• Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
• Min 4-5 year experience in a regulatory affairs environment
• Min 4-5 year experience in the pharmaceutical industry
• Detailed knowledge of EU and other regions current registration requirements for dossier preparation and procedure running
• Solid knowledge of specific national requirements in EU and other regions
• Knowledge of IT tools specific for in RA and pharmaceutical sector (e.g. eCTD, databases, change control management etc.)