Regulatory Affairs Manager

Regulatory Affairs Manager wanted for our Zug based client in the pharma sector.

YOUR EXPERIENCE/SKILLS:

- Degree in Pharmacy, Life Sciences or equivalent and solid experience in Swissmedic
- 3+ years of extensive work experience in regulatory affairs or drug development in the pharmaceutical industry
- Expertise in regulatory management, life cycle management, quality assurance and in development of new products as well as maintenance of the existing portfolio
- Languages: fluent German, English both written and spoken, conversational French

YOUR TASKS:

- Maintaining and sustaining relevant contacts to health authorities as well as supporting the product development team in organizing the Swissmedic meetings
- Collaborating with Swissmedic and upgrading internal processes along with monitoring changes related to regulatory issues
- Developing and establishing Swiss-specific parts of regulatory dossiers such as information for professionals and patient/packaging information
- Evaluating status of local post-approval commitments and ensuring their delivery time
- Cooperating with the relevant line functions to assure optimal launch preparation for new products besides
- Assuring proper handling of deviations and CAPA handling regarding RA related compliance issues and reporting adverse event/technical quality complaint to the related safety desk

START: 01/2017
DURATION: 03MM++
LOCATION: Zug, Switzerland
REF.NR.: BH10129

Does that sound interesting? Does that sound like a challenging opportunity to you? Then take the next step and send us your CV as a Word Document and a daytime contact telephone number.

DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.

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