CMC EU Regulatory Manager
vor 4 Wochen
CMC EU Regulatory Manager - Pharma vacancy for a globally operating Glattpark based company in the Pharma sector.
Your tasks:
- Designing and implementing comprehensive EU regulatory strategies to support product approvals and patient access
- Working closely with regional Market Access and Integrated Franchise Teams to ensure regulatory strategies are integrated into wider business goals
- Managing regional regulatory submissions, coordinating with health authorities, and ensuring timely approvals through product lifecycle
- Offering strategic advice to internal teams, ensuring that development programs comply fully with EU regulations and operate efficiently
- Overseeing CMC regulatory responsibilities, including managing post-approval changes and product updates to maintain EU compliance
Your experience/knowledge:
- In-depth understanding of EU regulations and guidelines for drug and biologics development, including post-marketing requirements
- Strong grasp of regulatory affairs concepts and their impact across departments and global functions
- Proven experience in managing relationships with Contract Research Organizations and other external partners is highly desirable
- University degree or equivalent experience in a relevant field
- Language skills: English - fluent
Your soft skills:
- Excellent comprehension skills with attention to detail
- A high degree of self-organisation and time management
- Analytical and solution-orientated thinking
Location: Glattpark, Switzerland
Work setting: Hybrid
Sector: Pharma
Start: 11/2024
Duration: 06+ MM
Workload: 100%
Ref. Nr.: BH 22293
Take the next step and send us your resume along with a daytime phone number where we can reach you.
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