Overview
Regulatory Affairs CMC Senior Manager
Hertfordshire, UK – Hybrid
An exciting opportunity to join an established pharmaceutical company that specialises in Oncology and Neurology. The role will be working across both portfolios and will have a heavy focus on regulatory strategy. This is an exciting opportunity to demonstrate your knowledge in managing regulatory processes from authoring CMC sections for developing biological/Small Molecule products, including working as an SME for RA CMC processes.
A great opportunity to demonstrate your knowledge in leading regulatory processes for products across the globe, with a focus on oncology and neurology. In this unique position, you will interact with a wide and diverse range of colleagues across the organization.
Key Responsibilities:
1. Support regulatory CMC writing activities including authoring CMC sections.
2. Lead preparation of submission dossiers. This includes reviewing CTD dossiers such as M3/source documents, and authoring of QOS (M2.3), as well as creating of RtQs from Health Authority as needed.
3. The position will be focused on CMC and will need a Good understanding of CMC lifecycle maintenance activities across EU and international markets.
4. Supporting global CMC regulatory strategy including working cross-functional with key stakeholders inside and outside the organisation.
5. Prepare and coordinate the review and approval of submission-ready documents.
6. Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations.
Experience:
7. Education; Minimum of a Bachelor’s degree in a Scientific or Technical Discipline; Advanced Degree (MS. Ph.D.) preferred.
8. A highly specialized individual contributor with advanced CMC regulatory knowledge and expertise in a professional discipline.
9. 6-10 years of CORE regulatory CMC experience ideally in both small and large molecules.
10. Must have previous experience authoring Regulatory CMC sections for EU/US submissions.
11. Change Control assessment experience (application of relevant regulatory guidance to proposed change).
This is an excellent opportunity to work for a leading pharmaceutical company at the heart of science and neuroscience development. You will be supported by an established CMC team providing excellent career progression opportunities and a chance to work as a senior figure in the RA CMC team. The role comes with some excellent benefits, including a bonus, car allowance,e life assurance, pension scheme, and private healthcare.
This role does not provide sponsorship and you must have the Right to Work in the UK.
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