Senior Regulatory Affairs Manager (m/f)

- Work in-house within the Global Regulatory Affairs team and support the Global Regulatory Affairs team in the management of marketed products
- Manage the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation (mainly Europe, Canada and Australia)
- Management of the regulatory day-to-day agency interactions (mainly with EMA) and act as agency liaison for CTAs/INDs
- Liaise with functions in the headquarter and the regulatory affairs units in countries
- Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs
- Represent Global Regulatory Affairs in project teams and clinical trial teams

- Degree in a life science or related discipline, higher degree preferable (PhD, MSc, MBA)
- Profound experience in regulatory affairs
- Experience with NCEs / NBEs (New Chemical Entities / New Biological Entities) products, one with device experience
- Experience in regulatory agency interactions and preparation of documentation to support interactions
- Knowledge in therapeutic areas endocrinology, fertility, neurodegenerative diseases and oncology preferable
- In-depth knowledge of marketed product maintenance requirements in Europe (PSURs, renewals, CMC and labeling variations) familiar with international requirements
- In-depth knowledge of European regulatory pathways (CP, DCP/MRP, national procedures)
- Experience in preparation and management of Clinical Trial Applications to major European and international health authorities
- Experience in lifecycle management activities in at least two regions (among them Europe ), i.e. ability to prepare regulatory strategies for LCM projects

Weitere Qualifikationen: Regulatory affairs manager, Drug regulatory affairs manager, Head of regulatory affairs