Regulatory Affairs Cmc Associate Manager
Vor 2 Tagen
For our customer located in Basel/Switzerland we are currently looking for a**: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 high-quality 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 docu-ments 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 patient-focused mindset
- Ability to work successfully with global project teams and prioritize activities considering timelines and workload
- Well-developed planning, organizational, negotiation, problem solving and interpersonal skills
- Computer/IT systems literacy
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