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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
Responsibilities
- Coordinate the preparation, submission, and maintenance of regulatory applications for clinical and non-clinical development programs
- Support lifecycle management activities for marketed products, including product information updates and promotional material reviews
- Contribute to the development and implementation of regulatory strategies aligned with business objectives
- Collaborate closely with cross-functional teams to integrate regulatory requirements into development and lifecycle plans
- Support interactions with regulatory authorities, including preparation of briefing documents and meeting coordination
- Act as a local regulatory contact for Swissmedic and ensure submissions meet local requirements
- Manage regulatory authority questions, commitments, and responses in collaboration with internal stakeholders
- Maintain regulatory documentation, submission tracking, and archiving...