Manager Regulatory Affairs CMC 60 - 80%

Tillotts Pharma AG — Rheinfelden
15 AprilFach­ver­ant­wortung60 – 80%

For our dedicated Regulatory Affairs team we are looking for a new team member.

Manager Regulatory Affairs CMC 60 - 80%

» Vacancies » Manager Regulatory Affairs CMC 60 – 80%

 

 

  • Communicate and formulate CMC issues across functional teams
  • Act as regulatory CMC assessor and strategist
  • Manage the preparation, writing, and functional review of global CMC documents (modules 3 and 2.3) for post-approval variations and related health authorities responses
  • Participate in interdisciplinary change management and evaluate the regulatory relevance of proposed CMC changes
  • Provide and summarise regulatory intelligence for the quality-related topics of interest

 

  • Master degree in pharmacy, chemistry, life science or similar education
  • Minimum 4 years’ experience in CMC Regulatory Affairs in the pharmaceutical industry
  • Solid experience in CTD module 3 handling and life-cycle management of market applications worldwide
  • Experienced in regulatory CMC assessment with strategic thinking and sense for practical solutions
  • Fluency in English & German (both negotiation skills)
  • Reliable team-player
  • Good communication skills and able to work independently on multiple tasks and under pressure in an organized manner

Tillotts Pharma (www.tillotts.com) is a fast-growing international specialty pharma company located outside of Basel, employing over 300 employees in Switzerland and abroad. More information can be found about us here. You can also learn more about Tillotts’ history here. Our employees will be happy to give you reasons why they enjoy working for Tillotts, and why we are a Great Place to Work® Not yet convinced? Have a look at our fringe benefits or contact our HR team, who will gladly provide more information about Tillotts.

Please note that we only accept direct applications (no recruitment companies)

- Human Resources, Tillotts Pharma AG

Tillotts Pharma AG
Frau Beatrice Strub
Baslerstrasse 15
4310 Rheinfelden

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