Role details

Regulatory Affairs Specialist

Geneva   •  Permanent

Bullet points

  • Our client is a fast growing Pharmaceutical company
  • Excellent Regulatory Affairs Specialist opportunity

About Our Client

Our client is a fast growing Pharmaceutical company.

Job Description

- Support submission and approval of applications for marketing applications in Switzerland
and International
- Manage submission and approval of variations in Switzerland Assist/develop regulatory strategies
- Participate in due diligence activities
- Maintain information on submission status
- Assure all regulatory files and HA correspondence are appropriately archived
- Support Medical Affairs/Pharmacovigilance activities

The Successful Applicant

Minimum 1-2 years experience in regulatory affairs
Experience with RA dossiers in Switzerland (experience with oral generics i.e. bioequivalence in Switzerland highly appreciated)
Development and preparation of successful regulatory strategies
Experience with regulatory agency interactions
eCTD experience
Experience with Medical Affairs/Pharmacovigilance is a plus
Project management skills
Pragmatic, focused on results and solutions

What's on Offer

An excellent opportunity in a fast growing Pharmaceutical company to grow and develop in a Regulatory Affairs Specialist position.

Apply for this job

Click the Apply or LinkedIn or XING or Viadeo button below or contact Ema Zoric quoting job reference 89428
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