Role OverviewThe Regulatory Affairs Manager is responsible for supporting and managing EU Marketing Authorisation Applications (MAA), lifecycle activities and supporting new MAAs. The role focuses on EMA submissions, authority interactions, and post-authorisation maintenance for centrally authorised medicinal products.

Key Responsibilities

• Lead and support EU MAAs via the Centralised Procedure (CP).
• Coordinate preparation, review, and submission of CTD/eCTD dossiers in line with EMA requirements.
• Act as the primary regulatory contact with the EMA.
• Support regulatory strategy for centrally authorised products.
• Manage post-authorisation activities, including variations, renewals, and commitments.
• Prepare and coordinate responses to LoQ, LoOI, and other EMA requests.
• Oversee labeling updates (SmPC, PIL, labeling) for centrally authorised products.
• Collaborate closely with CMC, Quality, Clinical, Pharmacovigilance, and Supply Chain teams.
• Maintain accurate regulatory records and submission tracking in regulatory systems.

Qualifications & Experience

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.
• 5+ years’ experience in EU Regulatory Affairs, with strong focus on the Centralised Procedure.
• Proven experience with EMA MAAs and lifecycle management of centrally authorised products.