Regulatory Affairs Manager Cmc

Vor 7 Tagen

Basel, Schweiz Coopers Group AG Vollzeit

Regulatory Affairs Manager CMC

For our client in Basel, we are looking for RA CMC Manager who will be responsible for global CMC submission activities for assigned projects.

**Responsibilities**:

- 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.
- Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stake holders.
- Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.

**Requirements**:

- Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Working knowledge/experience in regulatory submission and approval processes desirable.
- Demonstrated track record to successfully work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.

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