Regulatory Specialist API (m/f)

Zurich  ‐ Onsite
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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
Start date
ASAP
Duration
5 MM+
(extension possible)
From
Hays AG
Published at
03.11.2016
Contact person:
Kerstin Werner
Project ID:
1231594
Contract type
Freelance
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