31 Regulatory Affairs jobs in Ireland

Regulatory Affairs Associate Location:Dublin, Ireland Company:Xeolas Pharmaceuticals Department:Regulatory Affairs Reports To:Regulatory Affairs Manager About Xeolas Xeolas Pharmaceuticals is a proudly Irish-owned specialty pharmaceutical company based in Dublin, with a team of over 70 professionals. We develop and manufacture innovative, patient-friendly pharmaceutical products for international markets. As we expand our in-house capabilities, we are seeking a skilled Regulatory Affairs Associate to support our regulatory publishing and submission activities. Role Overview The Regulatory Affairs Associate will play a key role in supporting the preparation, publishing, and submission of regulatory documentation for both new applications and lifecycle maintenance of existing products. This position offers an excellent opportunity to contribute to a growing regulatory function within a dynamic and innovation-driven organization. Key Responsibilities Support the compilation of regulatory dossiers for EU and Rest of World (ROW) submissions. Assist in the preparation and submission of variations, responses to regulatory queries, and other regulatory documentation. Support with administrative tasks such as CPP, GMP and MIA request Perform operational tasks related to document authoring, including formatting, editing, reviewing, publishing, and archiving (both paper and electronic). Conduct quality reviews of submission documents to ensure accuracy, completeness, and compliance with regulatory standards. Manage project workflows throughout the submission lifecycle, ensuring timelines are met and proactively addressing issues or resource needs. Review of R&D documents for under development projects Stay informed of evolving regulatory requirements and submission standards. Undertake additional tasks as assigned by the Regulatory Affairs Manager. Qualifications & Experience Bachelors degree in Health Sciences or a related field, or equivalent relevant experience. 13 years of experience in the pharmaceutical regulatory industry. Solid understanding of regulatory affairs principles, applicable regulations, and guidance documents. Strong attention to detail, organizational skills, and ability to manage multiple priorities.

Regulatory Affairs Associate Location: Dublin, Ireland Company: Xeolas Pharmaceuticals Department: Regulatory Affairs Reports To: Regulatory Affairs Manager About Xeolas Xeolas Pharmaceuticals is a proudly Irish-owned specialty pharmaceutical company based in Dublin, with a team of over 70 professionals.

We develop and manufacture innovative, patient-friendly pharmaceutical products for international markets.

As we expand our in-house capabilities, we are seeking a skilled Regulatory Affairs Associate to support our regulatory publishing and submission activities.

Role Overview The Regulatory Affairs Associate will play a key role in supporting the preparation, publishing, and submission of regulatory documentation for both new applications and lifecycle maintenance of existing products.

This position offers an excellent opportunity to contribute to a growing regulatory function within a dynamic and innovation-driven organization.

Key Responsibilities Support the compilation of regulatory dossiers for EU and Rest of World (ROW) submissions.

Assist in the preparation and submission of variations, responses to regulatory queries, and other regulatory documentation.

Support with administrative tasks such as CPP, GMP and MIA request Perform operational tasks related to document authoring, including formatting, editing, reviewing, publishing, and archiving (both paper and electronic).

Conduct quality reviews of submission documents to ensure accuracy, completeness, and compliance with regulatory standards.

Manage project workflows throughout the submission lifecycle, ensuring timelines are met and proactively addressing issues or resource needs.

Review of R&D documents for under development projects Stay informed of evolving regulatory requirements and submission standards.

Undertake additional tasks as assigned by the Regulatory Affairs Manager.

Qualifications & Experience Bachelors degree in Health Sciences or a related field, or equivalent relevant experience.

13 years of experience in the pharmaceutical regulatory industry.

Solid understanding of regulatory affairs principles, applicable regulations, and guidance documents.

Strong attention to detail, organizational skills, and ability to manage multiple priorities.

Regulatory Affairs Manager Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities.

This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.

Role/Responsibilities Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle.

Manage regulatory submissions (e.g.

510(k), CE Mark) and global product registrations.

Act as the primary contact for regulatory agencies, including authorities in the U.

S.

and Europe.

Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance.

Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.

Review and approve promotional and advertising materials from a regulatory perspective.

Identify and allocate internal and external resources needed to maintain a robust regulatory function.

Provide strategic advice and cross-functional support on all regulatory matters.

Candidate Requirements Bachelors degree in Engineering, Life Sciences, or a health-related field.

10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.

In-depth knowledge of US FDA and EU medical device regulations (including MDR).

Proven ability to handle complex regulatory submissions and interactions.

Excellent organizational, leadership, and communication skills.

A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment.

Previous experience in an SME or medtech startup is highly desirable.

For further information please contact James Cassidy or call in confidence

**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Abbott in Ireland**
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
WHAT YOU'LL DO
**Responsibilities:**
- Regulatory project management for global programs (PIERs, Global Science Innovation, Supply Network, Strategic) without close supervision by manager.
- Lead strategic programs with supervision by manager.
- Develop and execute regulatory strategies to ensure successful registration and approval of international nutrition products.
- Represent Abbott Nutrition regulatory affairs on departmental and divisional teams, providing timely regulatory input and communication to ensure regulatory requirements are met.
- Analyse and identify regulatory requirements against project needs.
- Communicate registration needs before and during product development.
- Prepare options, suggestions, and/or a regulatory assessment for product registration to achieve global project goals.
- Execute plans, complete tasks according to priorities set by Manager, align work with business goals and align actions with agreed upon strategies.
- Excellent verbal and written communication skills and ability to effectively present scientific data to management.
- Assure established policies and standard interpretations of regulations are followed for assigned projects. Maintain an awareness of legislation and assess impact on Abbott business.
- Responsible for tracking and timely completion of regulatory assignments, registration assessments, and execution of filing
- Responsible for effective communication of regulatory requirements to project teams and internal customers (scientists, marketing, quality assurance, product development, affiliates).
- Accountable for compliance with internal SOPs and understanding & compliance with relevant Regulations.
- Position is highly visible to internal and external stakeholders.
**EDUCATION AND EXPERIENCE, YOU'LL BRING**
**Required:**
- Bachelor's degree is required (engineering, nutrition, chemistry or biological science is
preferred)
- 3 or more years of relevant experience (exposure to regulatory affairs is preferred)
- Project management experience and/or exposure to project management principles.
- High level of effective verbal and written communication skills, including ability to negotiate,
influence, and manage conflict.
- Able to work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates, etc.) to solve problems and communicate regulatory needs.
**Preferred:**
- Master's degree.
- Prior regulatory experience in the food industry.
- Knowledge of regulations relating to foods, infant formula manufacturing and/or consumer products.
- Manufacturing/Quality/Packaging or similar experience.
Connect with us at and on LinkedIn , Facebook , Instagram , X and YouTube .
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

At Regeneron, we're advancing science and medicine to improve lives. We're seeking a talented Regulatory Affairs Manager to join our team and play a pivotal role in supporting EU regulatory activities for oncology drug development. This is your chance to contribute to groundbreaking clinical development programs while collaborating with global experts and building relationships across the EU regulatory network. Join us in shaping the future of oncology treatments and making a meaningful impact on patients' lives. A Typical Day: As a Regulatory Affairs Manager, your day might include: Developing regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends. Managing CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements. Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents. Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions. Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings. Monitoring newly published EU Commission and EMA guidelines to ensure compliance and provide training for scientific staff. Representing Regeneron Regulatory Affairs in engagements with EMA scientific committees, EU national agencies, and industry associations. This Role May Be For You If: You are someone who: Thrives in a collaborative environment and enjoys working with multidisciplinary teams. Has a proven ability to navigate EU regulatory frameworks and requirements. Is detail-oriented and skilled in analyzing clinical and preclinical data. Has experience leading regulatory agency meetings and negotiating effectively with stakeholders. Is passionate about contributing to oncology drug development programs. Values continuous learning and stays updated on emerging regulatory trends. Has excellent written and verbal communication skills. To Be Considered: We're looking for candidates with: An advanced degree in a scientific discipline. At least 4 years of regulatory experience, with a focus on clinical development. Proven experience supporting EU Clinical Trial Applications through approval and study start-up. Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs. Experience in oncology regulatory strategy is an advantage. A strong ability to negotiate and express clear positions to stakeholders at all levels. Preferred qualifications include experience with marketing authorization applications or life-cycle management of approved products in the centralized procedure. Why Join Us? At Regeneron, we believe in fostering innovation, collaboration, and growth. You'll have the opportunity to work with a passionate team dedicated to advancing science and improving patient outcomes. Together, we'll make a difference. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Director of Regulatory Affairs Medical Device Start-Up Galway About the Company Our client is an ambitious, well-funded medical device start-up based in Galway, entering a critical phase of operational expansion. Backed by a proven management team with a strong track record in the start-up sector, the company is primed for significant growth both domestically and internationally. The Opportunity We are seeking a Director of Regulatory Affairs with a strong strategic vision and leadership capability to join the executive team. This is a key role where you will define and lead the companys global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly. Key Responsibilities Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities. Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines. Serve as the primary liaison with regulatory authorities, representing the company in all regulatory interactions and negotiations. Build and lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities. Monitor and interpret evolving regulatory requirements to ensure proactive compliance across multiple geographies. Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making. Support due diligence and partnership activities through regulatory assessments and strategy development. About You Minimum of 10 years experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role. Proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways essential). Strong understanding of the global regulatory environment, including emerging markets. Ability to think strategically while executing detailed regulatory plans. Exceptional leadership, communication, and stakeholder management skills. Comfortable operating in a fast-paced, high-growth, entrepreneurial environment. Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous. Whats on Offer The chance to be a key architect of the companys regulatory success during an exciting growth phase. A senior leadership role with real influence across the business. Competitive salary, equity participation, and an attractive benefits package. An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits. If interested in discussing further please contact James Cassidy or call in confidence

Position Overview We are seeking a highly motivated Regulatory Affairs CMC Specialist to join our Regulatory Affairs team at Helsinn Birex Pharmaceuticals Ltd, based in Dublin 15. In this role, you will support the management and maintenance of Marketing Authorisations (MAs) in compliance with European and international regulations. You will work closely with regulatory authorities, internal stakeholders, and external partners to ensure the smooth lifecycle management of our pharmaceutical products. Key Responsibilities Prepare and submit Marketing Authorisation Applications (MAAs), variations, renewals, and post-authorisation activities in line with European regulatory requirements. Manage communications and respond to queries from regulatory authorities (EMA, EU and non-EEA competent authorities). Publish dossiers and submissions using validated document management systems and ensure correct electronic formats. Ensure compliance between authorised Marketing Authorisations and manufacturing site procedures. Review and evaluate proposed changes related to quality, manufacturing, supply chain, and Contract Manufacturing Organisations (CMOs). Review and approve product artwork to ensure regulatory compliance. Liaise with Helsinns corporate office and licensing partners to support regulatory activities. Manage correspondence and compliance activities with the HPRA, including manufacturing and active substance registrations. Review GMP documentation (specifications, batch records, analytical methods) related to regulatory compliance. Maintain up-to-date regulatory status information and circulate regulatory approval notices internally. Contribute to continuous improvement initiatives within Regulatory Affairs. Adhere to company policies, cGMP, EHS, and quality standards. Required Qualifications and Experience Bachelors degree in Pharmacy, Chemistry, Life Sciences, or a related discipline. Minimum 5 years of experience in pharmaceutical regulatory affairs, with a focus on CMC (Chemistry, Manufacturing, and Controls) activities. Proven experience preparing and submitting Marketing Authorisation Applications and related documentation in the EU. Knowledge of EU pharmaceutical regulations, EMA guidelines, and experience liaising with regulatory authorities. Familiarity with GMP and quality systems in a pharmaceutical manufacturing environment. Experience using electronic document management and publishing systems. Strong attention to detail and organisational skills. Excellent written and verbal communication skills in English. Ability to work independently and collaboratively within a team. Key Competencies Regulatory Knowledge: Strong understanding of regulatory frameworks applicable to pharmaceutical products in the EU and internationally. Analytical Thinking: Ability to evaluate complex data and regulatory requirements effectively. Communication: Clear and professional communication with internal teams, regulatory authorities, and external partners. Project Management: Ability to manage multiple tasks and deadlines while maintaining high-quality standards. Problem Solving: Proactive in identifying issues and proposing compliant solutions. Teamwork: Collaborative approach to working with colleagues and cross-functional teams. Integrity & Ethics: Commitment to confidentiality, compliance, and ethical conduct. Adaptability: Flexible and responsive to changing regulatory requirements and business needs. Skills: Regulatory Affairs CMC Marketing Authorisation Applications Pharma GMP Pharmaceutical Regulations Benefits: Health Insurance Performance Bonus Pension Scheme Parking Space with EV Charger Flex Time Work from Home Scheme

Join a Dynamic Regulatory Team in the Plant Protection Industry! The Client: For over thirty years, our client, an Irish-owned family firm, has been a trusted supplier of plant protection products. They are keen on making sure their customers have a good experience all round, building proper long-lasting relationships, and keeping them coming back for more through good old-fashioned loyalty. At the heart of what they do, you'll find integrity, respect, honesty, and accountability. As they keep going from strength to strength, they are looking to bolster their Regulatory team and need a bright spark for this key Senior Regulatory Affairs Executive role. They are quite flexible, offering remote or hybrid options depending on where you're based in Ireland, the UK, or across Europe. The Opportunity: Reporting straight to the Regulatory Affairs Manager, this is a proper strategic role where you can really make your mark and help shape the clients regulatory future. As Senior Regulatory Affairs Executive, you'll be key in getting regulatory applications sorted and submitted in important EU markets. This role gives the right person an opportunity to get stuck in with a supportive team, have a real say in decisions, and help work out regulatory strategy. To do well here, you'll need to be a good communicator, able to build and keep up strong relationships with the Regulatory Authorities, external consultants, and Contract Research Organisations (CROs). You'll be representing the client in a professional manner. Top-notch project management and the ability to juggle a few things at once are a must to make sure regulatory targets are hit on time. What You'll Bring to the Table: A minimum of 2 years under your belt in regulatory affairs gained in a generic R&D company, consultancy, or CRO. Familiarity with Article 34 of EU Regulation 1107/2009 in crop protection product (PPP) dossiers. Excellent written and spoken English, able to explain complicated stuff clearly and concisely. A team player through and through, with a knack for working well with others. A can-do, solution-focused attitude with a real drive to get things done. Great organisational skills and a keen eye for detail. The ability to build and maintain strong, productive relationships with all sorts of people. Bonus Points If You Have: Knowledge of the crop protection industry, including the technical side, commercial bits, farming methods, and specific crop issues. Fluency in another major European language. What's in it for You: A competitive salary that reflects your experience. The flexibility of working remotely or a mix of home and office, depending on where you are. The chance to work for a sound and growing Irish-owned company with a good reputation. A real opportunity to get involved in important decisions and help shape our regulatory approach. A supportive and friendly team where your contributions are valued. Chances to grow and develop your career in the regulatory field. Contact Caitriona Breaw @ Amicus for more information.

Regulatory Affairs Senior Specialist ABOUT XEOLAS Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufactureinnovativepatient friendly pharmaceutical products for international markets. We are now seeking an experiencedRegulatory Affairs Senior Specialistas weexpand. OVERALL ROLE OBJECTIVE The Regulatory Affairs Senior Specialist will report directly to the Regulatory Affairs Manager and be involved in all aspects of regulatory affairs of the company including existing licensed products as well as products under development. SPECIFIC RESPONSIBILITIES Reporting To: Manager Regulatory Affairs REQUIREMENTS: Preparation and maintenance of high quality dossiers (marketing authorisation applications/ Response to Health authority questions/ post-approval submissions). Submission of CPP/ Manufacturing authorisation requests to HPRA/MHRA Review of data intended for submission and advise regarding any deficiencies or issues. Ensure on-time submissions for all quality/ safety related changes for assigned projects. Preparation and submission of translated texts to EU/Non-EU countries Update of databases and systems for all products (in-line with current SOPs) Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities. Liaise closely with Business Development, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives. Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects. Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained. Embrace Xeolas values and behaviour Support the Xeolas business by participating in project teams to support departmental initiatives. On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Manager. KEYSKILLS /EXPERIENCE REQUIREMENTS For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Masters/ Bachelor's degree or equivalent in Science/Technology/ Pharmacy Minimum 7 years of Experience in Regulatory Capable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions. Must possess organization skills, time management skills and attention to detail. Excellent critical thinking and problem-solving abilities. Strong interpersonal and communication skills Experience in dealing with multiple stakeholders, both internal and external.