Location: A mixture of office working (Hertfordshire) & home working
Salary: Competitive Salary on offer + Bonus and Pension
The Regulatory Affairs CMC Expert will provide development stage CMC advice for a broad range of product types including New Chemical Entities, Biologics, Cell and Gene Therapy programmes. The role will require the following activities;
- Write IMPDs / INDs and quality related documentation for clinical development programmes.
- Advise CMC related strategies to ensure compliant clinical programmes leading into and throughout clinical studies.
- Implement robust CMC compliance programmes covering all aspects from monitoring changes to manufacturing processes, specifications and shelf life maintenance.
- Is a point of contact for agency interactions and negotiates pragmatic solutions during grounds for nonacceptance and throughout the duration of clinical studies.
- Leads CMC related discussions during scientific advice with National Agencies, the EMA, and FDA (including end of Phase 2 meetings).
- IMPD / IND and Module 3 dossier writing
- Degree or higher in Chemistry, Biochemistry, or related scientific disciplines
- Experience in leading CMC programmes at a technical level
- Prior experience in agency interactions and leading discussions with regulatory assessors
- Demonstrable experience in writing CMC/Module 3 dossier content, IMPDs and INDs for biologics products