Regulatory Affairs Officer

Besins Healthcare; Dublin; On-site; EUR 60,000 - 85,000; Full time

Job summary

Besins Healthcare in Ireland is seeking a Regulatory Affairs professional to manage global MAAs and regulatory submissions, lifecycle activities, and variations for the current and future pharmaceutical portfolio, ensuring compliance with applicable regulatory requirements and timelines.

The role involves drafting local modules and submission documents, compiling regulatory data from CMC/clinical teams, planning registrations, and coordinating with Health Authorities and internal stakeholders to

Qualifications

• Degree in Scientific, Pharmaceutical, Life Sciences or Regulatory Affairs.
• 2–3+ years of successful experience in Regulatory Affairs.
• Experience interacting with Health Authorities in one or more regions.

Responsibilities

• Prepare and file submissions including life-cycle maintenance variations, initial MAA filing, labelling updates, renewals, and transfers.
• Draft local modules and submission documents to ensure dossiers are available on time.
• Compile regulatory documents from other departments (CMC, clinical) for regulatory applications within timelines.
• Participate in planning and priority management of medicinal product registrations and propose regulatory strategies.
• Communicate effectively with internal/external stakeholders and health authorities; follow-up on submissions.
• Project management: quantify workload, plan resources and timelines, and track regulatory agency fees if relevant.

Skills

CTD knowledge

Lifecycle management

eCTD publishing

RIM systems

Regulatory affairs

Education

Science/Pharma degree

Tools

eCTD tools

RIM systems

Job description

Purpose of the job: Manage and support global Marketing Authorisation dossiers and regulatory submissions (MAAs, lifecycle activities, variations, transfers, etc.) for the current and future pharmaceutical portfolio, in compliance with applicable regulatory requirements and timelines.

About the Role

Main missions and responsibilities + expected results:

Responsibilities

• Accountability 1: Prepare (as relevant) and file submissions including: life-cycle maintenance variations, initial MAA filing, labelling updates, renewals, marketing authorisation transfers, in country(ies)/region(s) of responsibility and/or according to needs. Expected result: High quality regulatory submissions made on time.
• Accountability 2: Draft/write the local modules (ex: module 1), administrative documents and submission documents as relevant. Expected result: Submission dossiers available on time.
• Accountability 3: Compile regulatory documentation received from other departments (CMC, clinical) for regulatory applications in line with assigned timelines (including responses to questions). Expected result: According to agreed timelines.
• Accountability 4: Participate in the planning, execution and priority management of medicinal product registrations in areas of responsibility as relevant. Good overview of registration planning for area of responsibility and/or product responsible for at short-term/mid-term. Expected result: Propose regulatory strategies for submissions in areas of responsibility.
• Accountability 5: Effective high-quality communication with internal and external stakeholders, including local regulatory affairs colleagues or Health Authorities; participate in health authority meetings as relevant. Follow-up of submissions with local regulatory affairs/partners/HA as relevant. Expected result: Good communications and flow of information with internal and external stakeholders.
• Accountability 6: Project management: quantification of workload for each regulatory submission, resource planning and timelines for expected submission & approvals, project finance (regulatory agency fees related to regulatory submissions) if relevant. Expected result: Good traceability and accountability of ongoing submissions and planning.

Qualifications

• Degree in Scientific, Pharmaceutical, Life Sciences or Regulatory Affairs.
• 2–3+ years of successful experience in Regulatory Affairs.
• Experience interacting with Health Authorities in one or more regions.

Required Skills

• Good knowledge of the CTD structure and regulatory requirements for various submission types.
• Experience with lifecycle management activities (variations, renewals, labelling updates, etc.).
• Experience with eCTD publishing tools.
• Experience using Regulatory Information Management (RIM) systems.

Preferred Skills

• Strong attention to detail (critical for submissions accuracy).
• Excellent organisational and time management skills, with the ability to manage multiple priorities in a dynamic environment.
• Clear, effective communication skills across functions, regions and topics.
• Ability to work autonomously and follow structured processes.