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Regulatory Affairs Cmc Associate Manager
Vor 7 Tagen
:Regulatory Affairs CMC Associate Manager (M/F/x)**-
pay rate range - given by our client: 51 chf/h*Hiring Manager Job Description:
- As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high quality CMC regulatory documentation for our products and contribute to global regulatory submissions and strategies.
Tasks & Responsibilities
- Author highquality global CMC documentation for regulatory submissions throughout the product lifecycle for Biologics projects/products.
- Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Coordinate, collect, store source documentation needed for direct submission to Health Authorities.
- Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
Must Haves
Experience
- Experience in regulatory and/or in the pharmaceutical industry preferred
- Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the drug development process desirable.
Requirements:
- Education
- Degree in Science (e.g. Biochemistry, Biology, Biotechnology, Chemistry, Pharmacy) or equivalent. Advanced Degree in Science desirable
- Good oral and written communication skills with a collaborative and patientfocused mindset
- Ability to work successfully with global project teams and prioritize activities considering timelines and workload
- Welldeveloped planning, organizational, negotiation, problem solving and interpersonal skills
- Computer/IT systems literacy
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