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Regulatory Affairs CMC Associate Manager- 5139
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an Regulatory Affairs CMC Associate 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.
- Author high-quality global CMC documentation for regulatory submissions throughout the product lifecycle for Biologics projects/products.
- Apply agreed CMC global regulatory strategies, current regulatory trends and guide-lines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- 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
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us