Regulatory Affairs Manager
Regulatory Affairs Manager
- Art der Beschäftigung: Vollzeit
- 76.500 CHF – 104.500 CHF (von XING geschätzt)
- Vor Ort
Regulatory Affairs Manager
Über diesen Job
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.
