Reference Number: JO-2311-525331
Regulatory Affairs CMC Officer
Job Type: Permanent
Regulatory Affairs CMC – International Product Owner
Hertfordshire, UK (Remote)
Up to £50,000
Regulatory Affairs CMC – International Product Owner opportunity working for a rare disease biotech based in Hertfordshire. The business works across immunology, critical care and Coagulation Disorders and are looking for someone to join the CMC team and help support new registrations in the international markets.
As a Regulatory Affairs CMC – International Product Owner you will be responsible for driving the generation of appropriate and well-controlled technical documents maximizing the chances of first-time approval, and minimizing the need for change applications.
· Responsible for driving CMC changes and working as a technical expert related to CMC changes.
· Dealing with post-approval and lifecycle maintenance activities including variations, new MAA, renewals, and license changes for the ROW markets.
· Liaise early on with R&D, Production, Quality, Engineering and Validation to think through what would constitute a solid CMC data package with focus on reducing testing and in-process controls to what is necessary and sufficient.
· Develop standards to ensure good technical documents and speedy approvals due to reduction in requests for clarification and repeat questions while building knowledge of regulatory requirements and regulatory procedures to obtain new licenses and maintain existing licenses.
· Bachelor’s degree or higher in Life Sciences or technical field and around 4 years of experience in pharmaceuticals or a related industry. Advanced degree preferred.
· Previous experience working on CMC changes and authoring CMC sections for global submissions.
· Experience working
· In-depth knowledge of cGMPs (MHRA, US, EU,) for biologics and preferably plasma.
The role is an excellent opportunity to work on complex biologics within an innovative environment. This opportunity allows for great career progression opportunities as well as the opportunity to work remotely with the occasional meeting in the office in Hertfordshire. The role also includes a 10% bonus, private health insurance, pension, life insurance, and 25 days holiday.
If you are interested in this role or would like more details please email your CV to firstname.lastname@example.org
Please note to apply for this role you MUST have the full Right to Work in the UK and being living in the United Kingdom.