Regulatory Affairs CMC Expert [Senior Manager, Associate Director, Director]
Reports to: Techinical Director
Based at: Harlow, Essex CM20 2FB, UK. Depending on the experience of the candidate, some remote working could be considered.
The Regulatory Affairs CMC Expert provides development stage CMC advice to internal staff and to clients for a broad range of product types including New Chemical Entities, Biologics, Cell and Gene Therapy programmes. They will provide the following expertise based services:
- 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 non-acceptance 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).
- Leads interactions with contract manufacturing organisations and/or the technical teams within client organisations to extract data and guide activities to deliver a compliant programme that meets regulatory expectations
General Responsibilities and Duties of the Dept
Diamond BioPharm Limited is the Regulatory function within Diamond Pharma Services. The function provides end to end regulatory services and expertise driven product development advice from early stages of development through to post market support. Our regulatory division are experts in all aspects of European regulatory affairs providing support to clients in the following areas:
- Writing product development plans and providing gap analysis
- IMPD/IND writing
- Technical CMC support
- Preparing orphan applications, PIPs and PRIME submissions
- Assisting with scientific advice procedures
- Clinical Trial Application submissions
- GMO applications
- Ethics submissions
- Assistance in preparing and submitting variations and Marketing Authorisation Applications through the various Regulatory Authority procedures
- Acting as an overflow Regulatory Department
Key Responsibilities and Duties of the Role
- Provide world-class CMC advice across a range of product types
- Expert IMPD / IND and Module 3 dossier writer
- Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts.
- Provide CMC and development related strategy for a broad range of programmes
- Provide CMC advice and dossier support for US based programmes
- Regulatory lead and point of contact for national agency and EMA interactions
- Provide direct line management and matrix team based leadership
- High level of client focus and accountability
- 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
- Collaborative approach and able to work effectively with matrix based teams
- Advanced biologics experience, able to hold-their-own in discussions with contract manufacturers and the technical CMC teams within client organisations
- >5 years of experience in Regulatory Affairs
- >7 years of relevant experience in clinical development programmes
- Cell or Gene Therapy Experience
- Experience of technology transfer, analytical development, and process development in a related field.
- Exposure to MAA dossier writing and submission procedures
- Commitment to continual professional development and engagement with a professional body
- US FDA facing experience
- Innovative and pragmatic problem solver
- Attention to detail
- Strong communicator with the ability to influence
- Completer-finisher able to provide decisive leadership in a project team setting
- Ability to provide a flexible, proactive and dedicated approach whilst dealing with clients with different working styles and cultures.
- Strong client focus