Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager (CMC); Bern (Switzerland); 6 months; 105-119/hr CHF

My client, a well known pharmaceutical company is looking for a Senior Regulatory Affairs Manager for a medium term contract to be based at their site in Switzerland. They require someone who is able to draw on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any critical regulatory documentation of specified regulatory submissions.

This is an exciting opportunity to work for a company who embrace research and science and where you will be able to touch the lives of over a billion people every day.

Responsibilities:
*Responsible for designated products projects working within overall policies and strategies
*Prepares regulatory documentation for submissions such as clinical trial applications, marketing authorization applications, variations, renewals etc. in a timely and efficient manner.
*Responsible for dossiers establishment, timeplan coordination and regulatory submission plan and coordination of the activities between relevant function (development group, project team, clinical, etc.)
*Revise the CMC documentation and ensure good quality of the regulatory relevant documentation
*Prepares 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
*Prepares position papers and the regulatory sections of project plans for review and approval by supervisor
*Consulted on regulatory strategy, plans and manufacturing change control proposals
*Authorizes and drafts original texts (eg summaries, linking texts, labels and leaflets, letters). Reviews and comments on documents from other departments.
*Represents RA in project teams
*Being an interface between R
*Quick learner, motivated self-starter;
*Excellent customer service, interpersonal, communication and team collaboration skills;
*Able to follow change management for internal guidelines.

Language proficiencies:
*English spoken and written; German is nice to have.