#15211 | 12 months+ | Cambridge
James Carrera at Umbilical has partnered with an established Pharmaceutical client to source an experienced Regulatory Affairs Professional and CMC Specialist to join an established team to support International Regulatory Submissions.
- You will co-ordinate the preparation of high-quality CMC documents to support regulatory submissions in International regions, (Asia, Latin America, Middle East, Eastern Europe and Africa), as well as
- Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals
- Co-ordinate the preparation of responses to CMC questions from regulatory authorities
- Maintain an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organisation in a timely manner
You will have significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements, also;
- Highly capable in the preparation and finalization of CMC regulatory dossiers.
- Management of ongoing maintenance of existing product licenses
- Well versed and competent with regulatory documentation and submission management systems
- Excellent verbal, written and interpersonal communication skills
- Excellent organizational skills; the ability to work on a number of projects with tight timelines at the same time
For a confidential discussion, contact James Carrera at Umbilical