Description
We are looking for a
CMC Regulatory Specialist (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Support global CMC regulatory teams by helping to write CMC sections of post-approval marketing applications, assist in the renewal of and answering to deficiency letters
- Facilitate and support review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
- Assist the Technical Regulatory Leader in maintaining the 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
- Experience in post-approval submission is advantageous
- Attention to detail with excellent interpersonal skills
- Good English language speaking and writing skills
Skills:
- Regulatory affairs manager