Description
We are looking for a
Regulatory Specialist API (m/f)
Reference: -en
Start: ASAP
Duration: 5 MM+
Place: in the Zurich region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Ensure regulatory filing compliance as a basis to support the business for API production through developing and aligning regulatory filing strategies
- Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions: Coordination and preparation for new submissions, regular updates, variations and renewals
- Preparation and submission of Open Parts, Letter of Access, TSE Statement, Kosher/Halal Statement, Allergens Statement, Melamin free Statement, Latex free Statement, etc.) as well as the regulatory assessments of Change Requests and major non conformances
Your qualifications
- A university degree in the field of natural sciences relevant to the task in question and to a solid understanding of the relevant chemistry
- Solid experience, working in regulatory affairs within the pharmaceutical industry and outstanding knowledge of the respective, regulatory environment for APIs ( CMC )
- Great German and English Skills in both verbal and written form as well as great interpersonal and team - player attributes
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager