Ra Cmc Associate Manager

vor 2 Wochen

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**The Life Science Career Network**

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an **Regulatory Affairs CMC Manager** **for 18 month contract role based in Basel, Switzerland.**

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.

**Main 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 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.

**Qualifications and Experience**:

- **_Swiss working/residency permit and/or Swiss/EU-Citizenship required; _**:

- Degree in Science (e.g. Biochemistry, Biology, Biotechnology, Chemistry, Pharmacy) or equivalent. Advanced Degree in Science desirable
- 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.
- 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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