Manager - Regulatory Affairs
- Experience Level
Hobson Prior are seeking a Manager - Regulatory Affairs to join a global life sciences company who are recognised for protecting and enhancing life and driving innovation. This role will be located in Bern on a permanent basis.
- Represent Regulatory Affairs as the SME on assigned product/ project teams and ensure timely communication of regulatory strategy and plans to team members and line management.
- To develop regulatory strategy for assigned products and/or country.
- Plan and coordinate the preparation of regulatory submissions including meetings with health authorities and routine correspondence.
- Provide critical review of all documentation supporting regulatory applications.
- Provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management.
- Plan, coordinate, prepare and support meetings and teleconferences with regulatory agencies and submission meetings; may also be required to work with government funding agencies.
- To prepare responses to complex questions and comments from regulatory agencies.
- You will ensure regulatory product compliance for product.
- Effective in both written and oral communication.
- Multilingual - at least German and English, written and spoken.
- Ability to direct work as required and manage complexity.
- Ability to work on problems of diverse scope.
- Bachelor's degree in a life sciences or related discipline required.
- At least 8 years of relevant pharmaceutical industry experience, with minimum 5 years in Regulatory Affairs.
- Prior experience interacting with the FDA, EMA, Health Canada and/or other agencies as required.
- Identifies priorities and key issues in complex situations and solves with minimal assistance.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.