Senior Regulatory Affairs Manager

For our customer in Bern we are looking for a project ASAP for a

Senior Regulatory Affairs Specialist

This role demands the candidate to draw on relevant expertise and information from both internal and external sources, and make a major contribution towards the preparation of any critical regulatory documentation of specified regulatory submissions.

Responsibilities:

- Responsible for designated product projects working within overall policies and strategies
- Preparing regulatory documentation for submissions such as clinical trial applications, marketing authorization applications, variations, renewals etc. in a timely and efficient manner
- Responsible for dossier establishment, time-plan coordination and regulatory submission plan and coordination of the activities between relevant functions (development group, project team, clinical, etc.)
- Revising the CMC documentation and ensure good quality of the regulatory relevant documentation
- Preparing the concept for the final regulatory strategy with respect to WHO and is responsible for the harmonization of WHO and NRA strategies (issues, submissions, meeting etc.)
- Responsible for the good quality and conformity to regulatory requirements of the submissions
- Preparing position papers and the regulatory sections of project plans for review and approval by supervisor
- Consulting on regulatory strategy, plans and manufacturing change control proposals
- Authorizing and drafting original texts (eg summaries, linking texts, labels and leaflets, letters). Reviewing and commenting on documents from other departments.
- Representing RA in project teams
- Being an interface between R German is nice to have

Are you interested in this position? Then we are looking forward to receiving your application.