Inserat vom Mittwoch, 26. September 2018

Manager Regulatory Affairs CMC | Tillotts Global

Tillotts Pharma AGRheinfelden
  • Rheinfelden
  • Klein- und Mittelunternehmen
  • Festanstellung, 100%
  • Mitarbeiter

» Vacancies » Manager Regulatory Affairs CMC Tillotts Pharma (www.tillotts.com) is a fast-growing international specialty pharma company located outside of Basel employing over 300 employees in…

Manager Regulatory Affairs CMC | Tillotts Global

» Vacancies » Manager Regulatory Affairs CMC

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. We are dedicated to the development, in/out-licensing and marketing of innovative pharmaceutical products in the field of gastroenterology. We successfully market our own products as well as in-licensed products in over 65 countries through our affiliates as well as a network of carefully chosen licensing- and marketing partners. We are engaged in close collaborations with pharmaceuticals research centres and universities.

 

  • Manage and lead assigned regulatory CMC projects incl. management of time-lines and submission planning
  • 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 new marketing applications, responses to health authorities and post-approval variations
  • Participate in interdisciplinary change management and evaluate the regulatory relevance of proposed CMC-changes

 

  • University 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
  • Experience in preparation of CMC dossier in support of clinical trials (IMPD/IND)
  • Regulatory knowledge on biosimilars would be a plus
  • Fluency in English & German (both negotiation skills)
  • Reliable team-player which strategic thinking and sense for practical solutions
  • Good communication skills and able to work independently on multiple tasks and under pressure in an organized manner

If you are interested in this challenging position, please send your job application to

recruitment@tillotts.com

Electronic Communication with Tillotts: E-mails and documents sent via the Internet are neither confidential nor secure and could possibly be viewed and modified by third parties. Tillotts shall not be liable for damages arising from messages sent to Tillotts via unsecured e-mail. If you like to secure your electronic communication with Tillotts kindly send a blank e-mail with the following reference: request for encryption.

- Human Resources , Tillotts Pharma AG

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

- Human Resources , Tillotts Pharma AG

Tillotts Pharma AG
Baslerstrasse 15
4310 Rheinfelden
061 935 26 26

15 Jobs — Rheinfelden

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