Reference Number: JO-2207-496735
Senior Consultant CMC
Job Type: Permanent
Location: Central London / West End
Job Title: Senior Consultant CMC
Location: Homebased UK or Europe
Salary: 60,000 – 75,000 plus package
This is a fantastic opportunity to work within the global regulatory group of one of the world’s leading CRO’s, driving CMC activities across small molecule and biologic products at all stages of development.
- They will be part of the Regulatory Affairs (group, consists of approx. 320 people across the EMEA region
- Very large and interactive group, loss of cross region communication with peers, management, clients and project teams.
- Career path progression would be Regulatory Affairs Consultantto Senior Regulatory Affairs Consultant to Manager, Regulatory Affairs Consultant . No set timescale for progressing and management roles need to be available first.
- The position will be focused on CMC and will need a Good understanding of CMC lifecycle maintenance activities across EU and ROW markets
- Work collaboratively with RA CMC colleagues and SMEs to interpretand summarize complex data
- Prepare and coordinate the review and approval of submission-ready documents
- Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
- Strict adherence to timelines (both internal and HA deadlines)
- Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME
- Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory submissions throughout the product life cycle (IND, IMPD, NDA, MAA)
- Previous CRO, Pharma or Regulatory Agency experience is essential.
- Acted in the capacity of Sr Reg Affairs Associate or Consultant level.
- Good Regulatory Affairs experience with a minimum of3-5 years of CMC regulatory experience- ideally small molecules or Biologics
- Change Control assessment experience (application of relevant regulatory guidance to proposed change)
- CMC Submission experience of Simple (Type I) and complex variations (Type II) to EU markets in the CP, MRP and NP procedures.
- Experience working on simple and complex APAC and LATAM submissions would be of benefit.
- Thorough understanding of change management processes and regulatory requirements
- Strong problem solving and diplomacy skills
For further information please apply with an updated version of your CV and I will be in touch to discuss this further.