Senior Consultant CMC Biologics
Salary: Dependant on experience
Location: Remote in EU/UK
Permanent Position
Job Reference: JO-2101-460467
CPL Life Sciences are working a global CRO business who are looking for a Senior Consultant with expertise in CMC Biologics to join the team, working remotely in Europe. This is an exciting for a candidate with an extensive background in technical writing of regulatory documents who is now looking for the next step in their career.
Responsibilities:
- Drafting EU regulatory documents for M2.3 and M3 (drug substance)
- IMPDs
- scientific advice
- US experience with INDs, BLAs etc would be an advantage
- Ability to work on own initiative
- Ability to explain complex issues with biologic products
- Good attention to detail
Experience Required:
- Technical/writing CMC Submission packages biosimilars
- CMC Biologics (large molecule e.g. monoclonal antibodies, biosimilars, vaccines) experience is mandatory.
- Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
- High-level consulting skills
Please apply with an updated CV or contact chris.bart@cpl.com for further details.
