Beschreibung
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 lifecycle.
- 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.
Ideal Background:
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
Requirements:
- 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 Currently we have a number of roles within the pharmaceutical industry available please contact us to discuss this role further and other opportunities we are currently working on.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.