Beschreibung
We are looking for a
CMC Regulatory Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Support global CMC regulatory teams by writing CMC sections of post-approval marketing applications
- Establish renewals and answers to deficiency letters
- Perform regulatory assessment of change controls and discrepancies
- Support and facilitate review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
- Support shareholders (mainly Quality) in term of CMC regulatory oversight
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 with post-approval submission is advantageous
- Detail oriented with excellent interpersonal skills
- English-language speaking and written skills are required
Skills:
- Regulatory affairs manager