Reg Cmc Manager

vor 3 Wochen


Basel, Schweiz nemensis ag Vollzeit

At nemensis ag, we connected thousands of applicants with their dream jobs and gave them the opportunity to develop or re-enter the job market. For our client, an international company in Basel, we are in search for a RA RegCMC Manager.
- **
Employment type: Temporary via nemensis ag, 100%**:

- ** Duration: 01/02/2023 - 31/07/2024**:

- ** Salary: CHF 62. /h**

**Your responsibilities**:

- Support all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned 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 roject 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.

**Your profile**:

- Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
- Fluent English required (oral and written). Excellent written/spoken communication skills.
- Working knowledge/experience in regulatory submission and approval processes 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 product development and life cycle desirable.

For further questions please contact:



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