Description
Job description:
- Coordinate CTAs, amendments, orphan drug applications, paediatric plans, and annual reports.
- Maintain product information and assess promotional materials.
- Collaborate with internal stakeholders to implement regulatory strategy.
- Assist in agency meeting preparation and briefing documents.
- Track queries and commitments with regulatory agencies, ensuring timely responses.
- Manage regulatory documents in internal systems, including submission tracking and archiving.
Requirements:
- 3-5 years of experience in a Regulatory Affairs capacity within the pharmaceutical industry.
- Demonstrated interaction with SwissMedic and solid understanding of Swiss regulatory requirements.
- Hands-on experience with CTAs and MAAs in Switzerland.
- Strong understanding of the drug development process.
- Excellent communication and planning skills, with a detail-oriented and proactive approach.