Regulatory Affairs Manager CMC
Posted on Aug 30, 2019 by Michael Bailey Associates - UK Contracts
The leading global pharmaceutical company in Switzerland, has a new opportunity for a Regulatory Affairs CMC manager to provide support to all CMC related tasks.
This is initially 8 months contract role and may be extended, based in the office in Switzerland.
Your other job responsibilities would include:
- Authoring CMC documentation for HA submission, applying agreed CMC global regulatory strategies, assuring technical and regulatory compliance,
- Preparing responses to health authority questions during development, registration and product life cycle.
- Identifying the required documentation for global submissions and negotiating the delivery of approved technical source documents in accordance with project timelines.
- Identifying any issues with source documents, or any other potential issues that may impact submission quality or timelines, as early as possible.
- Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
- Prior experience in regulatory affairs CMC/Module 3 in drug/biopharmaceuticals
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology, preferably in small molecules.
- Knowledge of the drug development process is desirable.
- Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
Please apply now by sending a word document of your CV or contact Neha Sharma on (see below)
Michael Bailey International is acting as an Employment Business in relation to this vacancy.