Description
We are looking for a
Regulatory Affairs Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: in Kaiseraugst
Branch: Herstellung von homogenisierten und diätetischen Nahrungsmitteln
Your tasks:
- Leading the joint efforts for the development of product approval strategies in a timely and accurate manner
- Managing dossier preparation for product approval in collaboration with product and project management
- Assisting in the preparation and maintenance of company/product documentation compliant to law
- Being responsible for global (e.g. JECFA) or regional (e.g. CRN; ERNA; APIC) representation, networking and shaping activities
- Providing input on changing regulatory environments
- Support TQM for product specific aspects in customer Quality agreements
- Managing issues related to product quality aspects, e.g. impurity CCR in close cooperation with all internal functions (e.g. QA, Marketing & Sales, DSCM, PM)
- Representing the client in external working groups as participant and in contact with officials from authorities and auditing units
Your qualifications
- University degree in natural sciences and/or life sciences
- In-depth experience in the field of pharma regulatory affairs/quality
- Interdisciplinary knowledge in the areas of analytics, chemistry and production process, biology and toxicology (solid basics)
- Knowledge on regulations and standards for DNP and DFS business
- Fluent in English, every additional language beneficial
- Strong communication skills and good team working skills
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager