Regulatory Affairs and Pharmacovigilance Manager (m/w/d)
The Regulatory Affairs (RA) and Pharmacovigilance (PV) Manager serves as the internal global regulatory CMC (chemistry, manufacturing and controls – module 3) expert for the pharmaceutical products and provides support for the PV activities and processes. The RA and PV Manager partners with stakeholders to ensure proactive and effective RA and PV support related to the development, registration and lifecycle management, while also ensuring compliance with international regulatory and PV standards.
- Prepares regulatory documentation (specifically the quality sections, but not limited to this) to support marketing authorization applications.
- Prepares regulatory documentation and submissions for maintenance of marketing authorizations (e.g. compliance, post-approval changes, renewals, management of deficiency letters, annual reports) to support lifecycle management.
- Prepares documents to support Company establishment and local manufacturing permits for the Company manufacturing sites.
- Interacts with Company stakeholders, providing regulatory support and input as needed, by acting as regulatory CMC representative in internal project teams and other functional teams.
- Drafts and reviews documents detailing PV processes and supporting PV activities such as inspections, audits, signal detection, risk assessment/management, periodic safety reports, interactions with consultants/vendors supporting PV activities.
- Drafts documents from content provided by contributing authors and collects and incorporates comments from team members into various application types (eg IND (investigational new drug), NDA (new drug application), CTA (clinical trial application), MAA (marketing authorization application)).
- Interacts with regulatory authorities (e.g. EMA (European Medicines Agency), FDA (US Food and Drug Administration)) throughout development, registration, and lifecycle management.