Description
We are looking for a
CMC Regulatory Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Support the global CMC regulatory teams in writing CMC sections, support in renewals and answers to deficiency letters
- Support and facilitate reviews of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
- Support Technical Regulatory Leader to maintain system and databases
Your qualifications
- University degree in chemistry, pharmacy, life sciences or equivalent
- Experience in pharmaceutical CMC regulatory affairs, formulation development, quality, or analytical development is required; experience in post-approval submission is advantageous
- Fluent English skils, both written and verbal
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager CMC chemistry pharmacy life sciences formulation development