Regulatory Affairs CMC Senior Manager
Jocelyn Blackham is recruiting for a Senior Manager, Regulatory Affairs (CMC) to join a leading pharmaceutical company in the Basel area on a contract basis until the end of December 2022.
The main purpose of the role will be to:
- Provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies
- Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC globalregulatory strategies
- Prepare CMC responses to health authority questions during development, registration and product lifecycle
Further responsibilities will include:
- Identifying content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible
- Actively participating as a member of the global team by contributing to the regulatory strategy, identifying the critical issuesand lessons learned
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent is required
- Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent, is desirable
- Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable
This is an excellent opportunity to join a global pharmaceutical company.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 oremail jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 52230 in all correspondence.
