Regulatory Affairs Director

3 weeks ago


Essex, United Kingdom CK Group Full time

Job Summary

CK Group is seeking a highly skilled Regulatory Affairs Manager to join a global pharmaceutical company in Harlow. This is a contract role, covering maternity leave for 8 months.



Key Responsibilities




  • Oversee UK/IE Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar, and OTC products.
  • Deliver new submission work plans for allocated products, ensuring timely regulatory approvals for on-time launches.
  • Manage regulatory post-approval obligations to maintain compliance, ensure on-time launches, and continuity of supply.
  • Develop and provide regulatory strategies, guidance, and support for product development, local co-development initiatives, and in-license of new products.


Requirements




  • Proven experience in pharmaceutical regulatory affairs.
  • Demonstrated expertise in working with MHRA and HPRA, with a strong track record of regulatory submissions.
  • Substantial experience in new submission and post-approval submissions for various dosage forms, including generics, new chemical entities, devices, and OTC products.
  • A working knowledge of CTAs, paediatric investigation plans, and orphan designations.
  • Strong regulatory strategy development skills, with a focus on innovative solutions for project teams and health authorities.
  • Risk assessment and project management skills.


About Our Client



Our client aims to be a global leader in generics and biopharmaceuticals, improving patients' lives worldwide.



Location



This role is based at our client's site in Harlow.



Application Guidelines



Please note that applicants must hold the right to work in the UK. Please quote the job reference in all correspondence.



Additionally, this role may be subject to a satisfactory DBS check.



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