Beschreibung
Senior CMC Manager- Switzerland - 9 month contractOur client, one of the leading companies within the Life Sciences worldwide is currently seeking a Senior CMC Manager, for a 9 month project in Geneva, Switzerland.
As a senior CMC manager you will be setting the Chemistry, Manufacturing and Control regulatory plan while also creating the strategy pertaining to the quality part of the worldwide core dossier for IMP.
Major tasks and requirements
- Act as GRA contact point for CMC regulatory strategy for assigned NCE products (development stage IND/CTA to life-cycle maintenance MAA/NDA)
- Lead or support regional Health Authority interactions and negotiations (US/EU/JAP/CHN/RoW) in close cooperation with CMC Development and GRA as necessary
- Ensure GRA-aligned regulatory input is incorporated into CMC development decision making at the Global Project Team level and CMC sub-Team
- Plan, write or review Quality/CMC regulatory documents which form the basis of worldwide submissions such as : IND/IMPDs, new marketing authorizations (BLA/MAA Modules 2 and 3), amendments, DSUR, applications for variations/sNDAs/CBE, line extensions, annual reports and renewals;
- Assess CCPs for their regulatory impact worldwide and interact with Manufacturing units to ensure that for each change control proposal, the regulatory implications have been considered - as required
- Support some critical Tech Operations projects including transfers - as required
- Practical experience in one of the following area for small molecules: manufacturing process development, transfers, validation or analytical development and quality management
- Ph.D. Degree in a Life Science or related discipline (minimum MSc or equivalent degree)
- Fluent in English. German and/or French would be an asset.
- Relevant working/residency permit or Swiss/EU-Citizenship required
I am a specialized recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word including your hourly rate expectation for immediate consideration.
You can reach me on or at (a.xenitidis'at'realstaffing.com)
Keywords: Chemistry, Manufacturing and Control, CMC, life-cycle management, NCE, QbD, IND, IMPD, small molecules, English