Role Overview The 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.