15 Regulatory Framework jobs in Ireland

Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: Regulatory Affairs Director Reporting to the Global Head of the Regulatory Affairs (RA), the RA Director will play a pivotal role in ensuring the highest standards of professional excellence, regulatory adherence and quality within the business. With overall responsibility for the management of RA projects at WuXi Biologics Ireland, leading and organizing the regulatory procedures in Ireland, following up on the legislation requirements and communicating with the relevant stakeholders. Department Description: As Regulatory Affairs Director, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the EU/US Lead. Your Responsibilities: Serve as the Regulatory CMC lead for internal and external project teams, acting as the primary point of contact for all critical regulatory matters. Manage a team of Regulatory Affairs professionals, including direct reports and SMEs of sub-teams. Lead interactions and formal communications with governmental agencies (e.g., EMA, HPRA, FDA) to support regulatory submissions and negotiations. Lead and coordinate Health Authority meetings and negotiations (e.g., scientific advice, pre-IND, pre-BLA/MAA), including development of briefing books, risk mitigation plans, and team rehearsals. Participate in departmental budget and revenue planning, execution, and reporting. Responsible for setting and tracking KPIs aligned to department and corporate goals. Oversee a significant regulatory affairs portfolio that may include 30+ global projects with a cumulative value exceeding $10 million, ensuring strategic alignment and regulatory excellence across programs. Drive RA developments, establishment, and improvement for Ireland and Germany sites. Represent the company attending regional and global regulatory strategy forums and high-level external regulatory negotiations, partnerships, and trade associations. Provide company-wide updates on regulatory trends, impact assessments, and draft guideline comment coordination through cross-functional engagement. Actively influence and guide cross-functional project teams, ensuring alignment of regulatory goals with project milestones and commercial objectives. to support integrated projects throughout the entire development lifecycle. Develop and maintain professional partnerships with both internal and external stakeholders. Drive the development of departmental regulatory strategy by anticipating emerging trends, conducting due diligence on new business opportunities, and providing strategic analysis from a regulatory perspective. Collaborate closely with RA senior leadership to shape and refine the long-term strategic roadmap for Regulatory CMC. Act as a role model for the RA function and the wider organization in adherence to the WuXi corporate core values, local site shared commitments/behaviors. Your Profile: Qualifications: Masters degree in Science or related field required. Experience with at least one major marketing application. Knowledge/Experience/Technical Competencies: In-depth knowledge of evolving regulatory requirement trends and guidance. Good understanding of complex biologics manufacturing science. Familiarity with CMC terminologies. Excellent project management skills including planning, organising and ability to motivate and lead others. Minimum of 10 years pharmaceutical industry experience in R&D, Regulatory CMC, or related functions, with at least 5 years working in regulatory affairs CMC. Extensive knowledge of regulatory requirements for biologics in the EU, and local regulatory requirements for drug manufacturing. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures). Strong knowledge of cGxP requirements and regulations. Knowledge of trouble shooting and problem-solving skills, e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc. Behavioural Competencies: Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams. Excellent leadership skills. Develops collaborative relationships with internal stakeholders and clients. Proven ability to influence across functions without direct authority to deliver complex projects and regulatory filings successfully and on time. Ability to think clearly and in a decisive manner; remain calm under adverse conditions. Understands issues, problems, and opportunities with an open mind and critical thinking skills. Demonstrated strength in strategic thinking, with the ability to make complex decisions and a willingness to manage challenging positions. Ability to drive for business continuous improvement and customer focused. Unquestionable ethics, professional integrity, and to demonstrate PROUD values consistent with WuXi Biologics. Other Requirements Fluent in English and German is desired. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission -Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Would you like to know more before you apply? Please visit us ator contact us viaWuXi Biologics is an equal opportunities employer. Skills: Leadership Quality Compliance Organisational Stakeholder Management Benefits: Bonus Parking Pension Sports & Social Club VHI

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

Group Regulatory Affairs Manager Pharmaceuticals (Hybrid) Location: Offices based near Dunboyne, Co. Meath, Ireland Our client is a thriving Irish pharmaceutical group experiencing significant growth. Through consistent organic expansion and strategic acquisitions they have built a strong portfolio of market-leading OTC and Prescription medicines. Their products are marketed across numerous EU countries, Australia, and New Zealand. Due to their continued expansion, they are seeking a highly motivated and experienced Group Regulatory Affairs Manager to join their growing team. This is a fantastic opportunity to make a tangible impact within a dynamic, family-run business that prioritises performance and offers excellent career progression. What You'll Do: As the Group Regulatory Affairs Manager, you'll play a crucial role in ensuring the clients diverse product portfolio complies with global regulatory frameworks. This is a hands-on management position where you'll be expected to get stuck in and drive results. Your key responsibilities will include: Developing and implementing robust regulatory strategies to support product development and lifecycle management, particularly for our expanding portfolio acquired through acquisitions. Leading and mentoring a team of Regulatory Affairs Officers, fostering a collaborative and high-performing environment. Efficiently integrating all new portfolio acquisitions across multiple international markets. Spearheading projects to identify and resolve gaps in regulatory dossiers. Leading high-level meetings with Regulatory Authorities. Driving the regulatory aspects of internationalizing products and pursuing reclassification when appropriate. Proactively monitoring and interpreting global regulatory trends and changes, ensuring the company is always ahead of the curve. Collaborating cross-functionally with our Quality and Commercial/Marketing teams to achieve overarching company objectives. What You'll Bring: Our client is looking for a resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs. Essential Experience & Knowledge: 8-10 years of progressive experience in Regulatory Affairs within the pharmaceutical industry (human health). Strong knowledge of global regulatory frameworks, including MRP, DCP, and CP procedures. Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries. A proactive, "roll up your sleeves" attitude with a strong drive to see tasks through to conclusion. Exceptional attention to detail and outstanding organisational skills. Ability to work autonomously, take initiative, and assume responsibility for your actions. Highly Desirable: Knowledge of medical device regulations. Experience with cosmetics regulations. Whats On Offer: Competitive Salary: A highly competitive salary, negotiable based on your experience. For a manager-level role like this. Performance-Based Bonuses: Your hard work and contributions will be recognized and rewarded through performance-based bonuses. Hybrid Working: Our client embraces a hybrid working model to offer flexibility while fostering team collaboration. You'll be required in their offices near Dunboyne, Co. Meath three days a week.They offerflexible start and finish times around their contracted 9-5 hours to help avoid peak traffic. Career Progression: With a turnover of €250 million and ambitious growth plans, the opportunities for professional development and career advancement within the company are significant. If you're a seasoned Regulatory Affairs professional looking for a challenging yet rewarding role within a rapidly expanding pharmaceutical group, we encourage you to apply! Benefits: Performance Bonus

As a Staff Regulatory Affairs Specialist based in Cork, you will play a key role in ensuring regulatory compliance for Stryker's medical devices across global markets. In addition, you will support product transfers between Stryker manufacturing sites and international markets, with a focus on CE Mark submissions and EU MDR compliance.
Reporting to the Regulatory Affairs Manager, you will collaborate with cross-functional teams and regulatory authorities throughout the product lifecycle to ensure timely approvals and ongoing market access.
**What you will do:**
+ Develop and execute regulatory strategies to support product transfers and international registrations.
+ Prepare and maintain regulatory submissions in compliance with EU MDR and other global regulations.
+ Evaluate technical documentation, clinical and nonclinical data, and labeling for regulatory compliance.
+ Advise internal stakeholders on requirements for quality, preclinical, and clinical data throughout the product lifecycle.
+ Monitor changes in global regulatory requirements and update strategies and processes accordingly.
+ Review proposed product changes and assess their impact on global registrations.
+ Communicate with global regulatory authorities during submission preparation, review, and post-approval phases.
+ Support internal audits and regulatory inspections as needed.
**What will you need:**
**_Required:_**
+ Bachelor's or Master's degree in Engineering, Science, or a related field. Master's degree in Regulatory Science or RAC certification is a plus.
+ Minimum 4 years of Regulatory Affairs experience in the medical device industry.
+ Proven experience with EU MDR and CE Marking processes.
+ Hands-on experience with international product registration and lifecycle maintenance.
+ Knowledge of Class III and II medical devices, ideally in instruments.
+ Strong written and verbal communication skills and attention to detail.
**_Preferred:_**
+ Experience supporting product transfer projects between global manufacturing sites.
+ Familiarity with additional international markets beyond Europe.
+ Background in sustaining RA for complex device portfolios.
Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.
**Additional information**
Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of 2 days a week on site at our location in Cork should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

This is a 12 month contract with full Stryker benefits.
**What you will do:**
+ Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a technical and/or tactical nature
+ Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
+ Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
+ Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
+ Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
+ Evaluates proposed products for regulatory classification and jurisdiction
+ Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
+ Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
+ Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
+ Negotiates with regulatory authorities throughout the product lifecycle
+ Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
+ Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
+ Assists other departments in the development of SOPs to ensure regulatory compliance
+ Provides regulatory input and technical guidance on global regulatory requirements to product development teams
+ Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
+ Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
+ Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
+ Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
+ Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
+ Provides regulatory information and guidance for proposed product claims/labeling
+ Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
+ Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
+ Monitors the progress of the regulatory authority review process through appropriate communications with the agency
+ Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
+ Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
**What you will need:**
+ BS in Engineering, Science, or related degree; or MS in Regulatory Science
+ Typically a minimum of 4 years' experience
#IJ
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

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

This is a 12 month contract with full Stryker benefits. What you will do: Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a technical and/or tactical nature Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.) Assists in the development of regulatory strategy and updates strategy based upon regulatory changes Evaluates proposed products for regulatory classification and jurisdiction Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes Negotiates with regulatory authorities throughout the product lifecycle Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Assists other departments in the development of SOPs to ensure regulatory compliance Provides regulatory input and technical guidance on global regulatory requirements to product development teams Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process Provides regulatory information and guidance for proposed product claims/labeling Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines Monitors the progress of the regulatory authority review process through appropriate communications with the agency Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees What you will need: BS in Engineering, Science, or related degree; or MS in Regulatory Science Typically a minimum of 4 years' experience #IJ To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

Senior Regulatory Affairs Officer Pharmaceuticals (Hybrid) Location: Offices based near Dunboyne, Co. Meath, Ireland Our client, a thriving Irish pharmaceutical group, is experiencing significant growth with market-leadingOTC and Prescription medicinesacross numerous EU countries, Australia, and New Zealand. Due to their continued expansion, they are seeking a highly motivated and experiencedSenior Regulatory Affairs Officerto join their growing team. This new position reports into the Regulatory Affairs Manager and offers a fantastic opportunity to make a tangible impact within a dynamic, family-run business that prioritises performance and offers excellent career progression. What You'll Do: As a Senior Regulatory Affairs Officer, you'll play a crucial role in ensuring the company's diverse product portfolio complies with global regulatory frameworks. This is a hands-on role where you'll be expected to get stuck in and drive results. Your key responsibilities will include: Ensuring the companys products comply with all relevant regulations and standards. Demonstrating knowledge and execution ofType IA, IB, and II Variations. Managinglicence transfersin various international territories. Reviewing promotional material for medicinal products. PreparingModule 1 documentationfor National Applications. Preparing for and participating in meetings with Regulatory Authorities. Dealing with regulatory aspects of internationalising products and applying for reclassification. Training and mentoring more junior team members on Regulatory processes and compliance requirements. Monitoring and interpreting regulatory trends and changes relevant to the industry, keeping the company appraised of these. What You'll Bring: Our client is looking for a resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs. Essential Experience & Knowledge: 3-4 years of progressive experiencein Regulatory Affairs within the pharmaceutical industry (human health). Demonstrable experience with pharmaceutical products, specificallyOTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries. Exceptional attention to detail and outstanding organisational skills. Capability to work on your own initiative and take responsibility for your course of action. Whats On Offer: Competitive Salary: A highly competitive salary, negotiable based on your experience. Performance-Based Bonuses:Your hard work and contributions will be recognised and rewarded through performance-based bonuses. Hybrid Working:The company embraces a hybrid working model, requiring you in their offices near Dunboyne, Co. Meaththree days a week,with flexibility for remote work 2 days per week. They also offer flexible start and finish times around their contracted 9-5 hours to help avoid peak traffic. Career Progression:With a turnover of €250 million and ambitious growth plans, the opportunities for professional development and career advancement within the company are significant. If you're a seasoned Regulatory Affairs professional looking for a challenging yet rewarding role within a rapidly expanding pharmaceutical group, we encourage you to apply!

Join a Dynamic Regulatory Team in the Crop 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. You'll be the point person on regulatory projects supporting their new product development and making sure existing product authorisations are renewed without a hitch. 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 a Bachelor of Science (BSc) degree in a Life Sciences, Science, or Agronomy subject. A good few years under your belt in regulatory affairs gained in a generic R&D company, consultancy, or CRO. A solid grasp of EU regulatory frameworks and how things work for crop protection products. Proper project management and multitasking skills with a proven track record of getting regulatory results. 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: Some 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. Contract Caitriona Breaw @ Amicus for more information. Benefits: Work From Home