Director Global CMC Regulatory Affairs

A leading Global Biopharmaceutical company are looking for a Regulatory CMC Lead to join them as their new Director of Global CMC Regulatory Affairs where your main focus will be to develop CMC Regulatory Strategy for complex Biological products across R&D and developmental programs through to MAA submission and product launch.

This is a Senior level, managerial position where you will use your technical expertise of Biological CMC Regulatory Affairs to ensure the successful development of novel Biologics and NCE's. You will have the opportunity to work with complex products and play an integral role in the commercialisation of life saving therapeutics.

This position can be based at any of our Clients UK based sites or from their offices in Europe. If based in the UK, you will have the opportunity to work at the comapny's Manufacturing site where you will work directly with the Technical Operations and Manufacturing teams.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Director Global CMC Regulatory Affairs will be varied however the key duties and responsibilities are as follows:

1. Work closely with internal stakeholders across Product Development, Technical Operations and Regulatory Affairs to provide CMC regulatory expertise on a range development programs to ensure the successful commercialisation of complex Biological and NCE products.

2. Develop CMC Regulatory Strategy for new products in development and work closely with the Global Regulatory Affairs team to ensure the integration of the CMC Regulatory Strategy to the overall regulatory strategy of assigned projects. You will be responsible for the Regulatory CMC strategic development for Briefing documents, ODD, PIP, PRIME and Clinical applications as well as MAA and BLA's.

3. Establish communication and positive relationships with worldwide Health and Regulatory Authorities to seek advice and validation of CMC strategy ensuring that all time lines are managed effectively.

4. Be accountable for CMC dossier generation including effective collaboration with Development teams and internal Subject Matter Experts to deliver effective, timely and compliant submissions across the development program through to commercialisation.

5. You will lead and develop a growing Regulatory team with a focus on CMC strategic development and act as the project lead for a range of products.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Director Global CMC Regulatory Affairs we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline with an extensive background in the Pharmaceutical industry where you have relevant exposure to the development of Pharmaceutical products from a Manufacturing and CMC stand point.

2. Proven industry experience of developing and leading CMC Regulatory Strategy in an R&D environment, ideally for complex Biological Pharmacewutical products including but not limited to peptides, proteins, antibodies, vaccines, complex NCE's and toxins.

3. A working knowledge and practical experience with technical and regulatory writing in a global environment with a proven understanding of CMC Regulatory processes and requirements for at a Global level, including but not limited to EU, US and APAC regions.

Key Words: Director | Regulatory Affairs | CMC | Manufacturing | Strategy | CMC Development | Product Development | Global Regulatory Affairs | Biopharmaceutical | Pharmaceutical | Biologics | Leadership

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.