nestlé - regulatory affairs cmc expert in la tour-de-peilz

posted
job type
temporary
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job details

posted
location
la tour-de-peilz, vaud
job category
Life Sciences
job type
temporary
reference number
205085-2
phone
058 201 53 10
apply now

job description

For our client Nestlé in La Tour-de-Peilz we are looking for an immediate on boarding a

Regulatory Affairs CMC Expert - 6 months

The position will be attached to the Head of Regulatory Affairs CMC.
The RA CMC expert is responsible for preparing and updating the CMC sections of assigned products (Rx or non-monograph OTC drugs). Prepares CMC sections for investigational and commercial products (IMPD, IND, MAA, NDA, ...). Establishes data requirements for CMC changes with Pharmaceutical Experts and Operations teams. Follows new CMC activities from initial project plan, dossier preparation, support for registration.

Main Activities and responsibilities:

  • Write/assemble CMC sections for new registration and life-cycle dossiers for Rx and non-monograph OTC drugs
  • Advise/validate regulatory feasibility and strategy of proposed CMC modifications with Pharmaceutical Experts and Operations (Change control)
  • Review data provided to support updates/variations; prepare variation dossiers, support registration and communicate final outcome
  • Ensure all CMC dossiers are stored in the company database and kept current
  • Responsible for management of the service provider contracted to support a project, if appropriate

qualification

  • BSc, MSc in a scientific discipline or Pharmacist
  • At least 5 years in CMC Regulatory Affairs
  • Experience with topical and systemic drugs (Small Molecules)
  • Focused on effective delivery of objectives, even when working with tight deadlines
  • Planning, organising and time management skills
  • Problem solving and analytical skills
  • Ability to identify opportunities/major issues and to communicate impact;
  • Demonstrated ability to deal with rapid change
  • Effective verbal and written communication skills in a cross functional environment
  • Fluent in English