Regulatory Affairs Manager

3 weeks ago

Dublin, Dublin City, Ireland Helsinn Group Full time

Join to apply for the Regulatory Affairs Manager role at Helsinn Group

4 days ago Be among the first 25 applicants

Join to apply for the Regulatory Affairs Manager role at Helsinn Group

  • We are seeking a skilled and experienced Regulatory Affairs Manager to lead our Regulatory Affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, providing regulatory guidance to the team and ensuring compliance with applicable requirements for our pharmaceutical products.
  • This position requires a combination of supervision responsibilities and hands-on involvement in regulatory operations, with a particular focus on GMP compliance, regulatory quality assurance, and regulatory CMC-related activities to support our manufacturing site.

Position Overview
  • We are seeking a skilled and experienced Regulatory Affairs Manager to lead our Regulatory Affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, providing regulatory guidance to the team and ensuring compliance with applicable requirements for our pharmaceutical products.
  • This position requires a combination of supervision responsibilities and hands-on involvement in regulatory operations, with a particular focus on GMP compliance, regulatory quality assurance, and regulatory CMC-related activities to support our manufacturing site.

Required Qualifications And Experience
  • A degree in Pharmacy, Life Sciences, or a related discipline. Postgraduate qualifications in Regulatory Affairs or Pharmaceutical Sciences are advantageous.
  • Minimum of 7 years of progressive experience in Regulatory Affairs within the pharmaceutical industry, including management responsibility.
  • Experience in CMC regulatory activities and documentation.
  • Experience in Regulatory Quality Assurance is highly desirable.
  • In-depth knowledge of European regulatory requirements (CP, DCP, MRP, national procedures) and familiarity with ROW markets is a plus.
  • Proven experience in people leadership, project management, and cross-functional collaboration.
  • Strong understanding of GMP, GDP, and pharmaceutical quality systems.
  • Experience supporting organizational changes and process improvements.

Key Responsibilities

Team Leadership:
  • Lead, develop, and manage the local Regulatory Affairs team to ensure high performance, collaboration, and compliance with training and development plans by providing guidance, support, and decision-making assistance.
  • Ensure that team members have clear objectives, up-to-date job descriptions, and adequate resources to meet operational goals.
  • Support team development through mentoring and knowledge sharing.
  • Manage departmental budgets and resource allocation to support current and future regulatory requirements.

Regulatory Operations
  • Plan, coordinate, oversee, and actively support the preparation and submission of new Marketing Authorisation Applications (MAAs), variations, renewals, and other post-approval activities in the territories assigned, according to the global strategies.
  • Handle complex regulatory submissions and provide hands-on support for critical projects.
  • Review and write /contribute to CMC sections for regulatory submissions using validated document management systems.
  • Lead the preparation and review of CMC documentation and adaptation of CMC parts for various territories based on local requirements.
  • Ensure timely and compliant submissions to EU or other international regulatory agencies, using validated publishing tools.
  • Track and evaluate the impact of the CMC changes across different markets.

GMP And Regulatory Quality Assurance
  • Maintain regulatory compliance between registered MA dossiers and manufacturing/site operations.
  • Oversee compliance with regulatory requirements for manufacturing, packaging, testing, and distribution activities.
  • Review and approve from a regulatory point of view, when necessary, GMP documentation, product artworks, and other regulated documents.
  • Support Quality Assurance during inspections and audits.
  • Ensure alignment between regulatory commitments and site operations.

Authority Interactions
  • Serve as the primary contact for interactions between HBP with regulatory authorities (e.g. HPRA, EMA), including attending meetings, managing correspondence, and preparing responses to queries.

Cross-functional Collaboration
  • Collaborate closely with Corporate Global Regulatory Affairs to align local activities with global regulatory strategy.
  • Work closely with Quality, Supply Chain, R&D, and Commercial teams and provide regulatory guidance and expertise to internal stakeholders.
  • Provide regulatory support to internal and external stakeholders, including provision of documentation, submission guidance, and communication of regulatory changes.

Compliance Management
  • Monitor regulatory changes affecting manufacturing operations and implement updates to processes and procedures as necessary.
  • Support organizational changes and process improvements from a regulatory perspective
  • Prepare, review, and maintain department SOPs.
  • Participate in internal initiatives and continuous improvement projects aligned with company objectives.

Key Competencies
  • Strategic and analytical thinking with a proactive approach to regulatory challenges.
  • Hands-on approach to regulatory activities with attention to detail.
  • Excellent communication skills, both written and verbal, with experience interacting with health authorities.
  • Demonstrated ability to manage multiple projects and deadlines in a dynamic environment.
  • High attention to detail and commitment to regulatory excellence and compliance.
  • Good communication skills with experience in cross-functional collaboration.
  • Problem-solving skills with a focus on practical solutions.
  • Adaptability to changing priorities and requirements.
  • Strong interpersonal and leadership skills, with a focus on team development and mentoring.

The Company

The Helsinn Group has a commercial presence in over 90 countries and has proven expertise in areas such as Oncology Supportive Care, and Pain and Inflammation medicines.

This job is based at the Group's finished pharmaceutical manufacturing plant, Helsinn Birex Pharmaceuticals Ltd (FDA and IMB approved) which has operated at Damastown Industrial Estate, Mulhuddart, since 1997. HBP develops, manufactures and packages finished dose forms in tablet, granulate, capsule and gel formats. In addition, the company carries out final packaging of special dosage forms such as sterile forms and softgel which are produced by its worldwide network of CMOs.

Skills

For more information, visit our website:

Regulatory Affairs CMC GMP Regulatory Submissions Pharmaceutical industry Biopharmaceuticals Biopharma

Benefits

Health Insurance Performance Bonus Car Allowance Pension Scheme Parking Space with EV Charger Flex Time Work from Home SchemeSeniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionLegal
  • IndustriesOperations Consulting

Referrals increase your chances of interviewing at Helsinn Group by 2x

Sign in to set job alerts for "Regulatory Affairs Manager" roles.

Dublin, County Dublin, Ireland 1 week ago

Regulatory Affairs & Entity Corporate Governance Manager for North Europe and the Middle East

Dublin, County Dublin, Ireland 3 weeks ago

Dublin 4, County Dublin, Ireland 2 weeks ago

Dublin, County Dublin, Ireland 3 months ago

Dublin 4, County Dublin, Ireland 3 weeks ago

Dublin, County Dublin, Ireland 2 weeks ago

Dublin, County Dublin, Ireland 1 month ago

Dublin, County Dublin, Ireland 1 month ago

Regulatory Manager - Banking Regulations

Dublin, County Dublin, Ireland 4 months ago

Program Manager, Regulatory Compliance - EMEA

Dublin, County Dublin, Ireland 1 week ago

Dublin, County Dublin, Ireland 1 week ago

Dublin, County Dublin, Ireland 2 weeks ago

Test Manager (Capital Markets/Regulatory Reporting)

Dublin, County Dublin, Ireland 3 days ago

FS Business Consulting - Finance Regulatory Reporting and Transformation - Manager - Dublin

Dublin 2, County Dublin, Ireland 2 weeks ago

FS Business Consulting - Finance & Risk Regulatory Reporting - Manager - Dublin

Dublin 2, County Dublin, Ireland 1 week ago

Dublin, County Dublin, Ireland 2 weeks ago

Dublin, County Dublin, Ireland 2 weeks ago

Product Safety and Regulatory Affairs Specialist

Dublin, County Dublin, Ireland 1 week ago

Market Surveillance Legal and Regulatory Governance - Programme Manager

Dublin, County Dublin, Ireland 2 days ago

Manager - Regulatory Advisory for Banking & Capital Markets

Dublin, County Dublin, Ireland 1 week ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

  • Regulatory Affairs Manager

    2 weeks ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to manage EU marketing authorisation dossiers and submissions for our pharmaceutical products.The successful candidate will be responsible for preparing and filing EU submissions, including lifecycle maintenance variations, initial MAA filling, labelling updates,...

  • Regulatory Affairs Manager

    2 weeks ago

    Dublin, Dublin City, Ireland Helsinn Group Full time

    Join to apply for the Regulatory Affairs Department Head role at Helsinn Group.We are seeking a skilled and experienced Regulatory Affairs Manager to lead our Regulatory Affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, providing regulatory guidance to the team, and ensuring compliance with applicable...

  • Regulatory Affairs Manager

    2 weeks ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Marketing Authorisation ManagerWe are seeking a highly experienced Regulatory Affairs professional to manage EU marketing authorisation dossiers and submissions, prepare and file EU submissions, write local modules and administrative documents, and communicate effectively with European Regulatory Authorities. A life science qualification and 2-3 years of...

  • Regulatory Affairs Manager

    1 week ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Job Description:We are seeking an experienced Regulatory Affairs Manager to join our team. In this role, you will be responsible for managing a team of Regulatory Affairs Officers and ensuring compliance with all relevant regulations and standards.About the Team:You will be part of a dynamic team that is responsible for managing the regulatory aspects of our...

  • Regulatory Affairs Manager

    1 week ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Regulatory Strategy ManagerWe are seeking a seasoned Regulatory Strategy Manager to lead our regulatory affairs efforts and develop effective strategies to support product registration and renewal.About the PositionThe ideal candidate will have a strong background in regulatory affairs, excellent communication and project management skills, and the ability...

  • Regulatory Affairs Manager

    2 weeks ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Regulatory Affairs SpecialistThe role of Regulatory Affairs Specialist is crucial in ensuring the compliance and effectiveness of regulatory strategies for pharmaceutical products.This position involves planning, executing, tracking, and reporting on operational registration and life-cycle management projects. Key responsibilities include:Leading assigned...

  • Pharmaceutical Regulatory Affairs Manager

    8 hours ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Regulatory Affairs ManagerWe are seeking a skilled and experienced Regulatory Affairs Manager to lead our regulatory affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, providing regulatory guidance to the team and ensuring compliance with applicable requirements for our pharmaceutical products.Key...

  • Regulatory Affairs Manager

    2 weeks ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Regulatory Affairs ManagerThis Regulatory Affairs Manager will lead the development of regulatory strategies, manage regulatory submissions, and collaborate with stakeholders to resolve regulatory issues. The role requires strong leadership skills, effective communication abilities, and the ability to manage multiple projects simultaneously.Key...

  • Regulatory Affairs Professional

    2 weeks ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Regulatory Affairs Technical Manager Job OverviewThis role is responsible for ensuring compliance with industry and regulatory requirements. The successful candidate will have experience in pharmaceutical regulatory affairs and a deep understanding of EU pharmaceutical regulatory guidelines.The Regulatory Affairs Technical Manager will contribute to the...

  • Regulatory Affairs Manager

    2 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Job Description FormA Regulatory Affairs Manager position is available in Dublin, working on behalf of a global pharmaceutical company.This full-time/hybrid role reports to the Global Regulatory Affairs Associate Director.The Role and Responsibilities:Lead and manage operational registration and life-cycle management projects for company products.Promote...