Regulatory Affairs Specialist – Submissions & Lifecycle

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

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