Associate Director, Regulatory Affairs Cmc

Associate Director, Regulatory Affairs CMC/ Senior Manager

Hertfordshire, UK

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. As a Regulatory Affairs, CMC lead for developing programs. 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:

• Support regulatory CMC writing activities including authoring CMC sections in development including, CTA, IND, BLA, NDA, IMPD, and MAA.
• 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.
• The position will be focused on CMC and will need a Good understanding of CMC lifecycle maintenance activities across EU and international markets.
• Supporting global CMC regulatory strategy including working cross-functional with key stakeholders inside and outside the organisation.
• 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. 

Experience:

•  Education; Minimum of a Bachelor’s degree in a Scientific or Technical Discipline; Advanced Degree (MS. Ph.D.) preferred.
• A highly specialized individual contributor with advanced CMC regulatory knowledge and expertise in a professional discipline.
• 6-10 years of CORE regulatory CMC experience ideally in both small and large molecules.  
• Must have previous experience authoring Regulatory Clinical CMC sections for EU/US submissions.
• 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 life assurance, pension scheme, and private healthcare.

This role does not provide sponsorship and you must have the Right to Work in the UK.

For more details about this position please feel free to contact