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Senior Specialist Regulatory Affairs (m/f/x)

Senior Specialist Regulatory Affairs (m/f/x)

Job Title: Senior Specialist Regulatory Affairs (m/f/x)
Contract Type: Permanent
Location: Zürich, Switzerland
Industry:
Salary: Swiss Franc120000 - Swiss Franc140000 per annum
Start Date: ASAP
Reference: RA_2020_41_1611049393
Contact Name: Sebastian Gotzler
Contact Email: s.gotzler@sciproglobal.de
Job Published: January 19, 2021 09:43

Job Description

Senior Specialist Regulatory Affairs (m/f/x) | Zurich | Pharma

In this position, you will be responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for medicinal products and communication of general regulatory requirements in support of licensing of the company's medicinal products.

What will your tasks as Senior Specialist Regulatory Affairs be?

  • Compile and submit, in a timely matter, regulatory documents according to regulatory requirements, with regulatory experience on local level, e.g. Swissmedic submissions, eCTD submissions and Lifecycle Management
  • Manage all regulatory activities in relation to a specific portfolio of drugs (product owner)
  • Respond to Swissmedic questions with strict deadlines
  • Maintain regulatory files in a format consistent with requirements
  • Obtain, maintain and update existing regulatory authorizations
  • Provide regulatory advice to project teams
  • Lead or represent Regulatory Affairs in project teams
  • Review promotional material for comp

Your requirements?

  • University degree in pharmacy or related scientific discipline; PhD will be an advantage
  • 3-5 years experience of working in Regulatory Affairs within a pharmaceutical company, Swissmedic, CRO or similar organization
  • Experience of working with Swissmedic
  • Proven ability to plan, coordinate and lead submission activities simultaneously
  • Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation
  • Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner
  • Solution and detail-oriented; well-organised and self-motivated
  • Fluency in German (at least C1) as well as very good English & French skills

Information about our client:

Our client is one of the largest pharmaceuticals & medical devices companies in the world. It's more than 40.000 employees are operating in 90+ countries. The diverse specialties of the company include critical care, hospital care as well as nutritional care and renal care. The company is striving for excellence by helping improve and personalize healthcare.

I look forward to your application!