Inserat vom Mittwoch, 17. Oktober 2018

Temporary Manager Regulatory Affairs CMC

Tillotts Pharma AGRheinfelden
  • Rheinfelden
  • Klein- und Mittelunternehmen
  • Temporär, 100%
  • Fach­verantwortung

» Vacancies » Temporary 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…

Temporary Manager Regulatory Affairs CMC

» Vacancies » Temporary 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.

 

  • Maternity cover (January – June 2019)
  • 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 (small molecules) in the pharmaceutical industry
  • Regulatory CMC knowledge on antibody would be a plus
  • Solid experience in CTD module 3 handling and life-cycle management of market applications worldwide
  • Experienced in regulatory CMC assessment
  • Very good English and German skills (especially CMC writing skills in English)
  • 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

Tillotts Pharma AG
Baslerstrasse 15
4310 Rheinfelden

12 Jobs — Rheinfelden

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