Job description:
 

Do you want to develop your career in exciting new medical technologies? We deliver life-changing gene therapies to patients, and so can you.

Oxford Biomedica’s Regulatory team is responsible for developing and executing worldwide regulatory strategies, be responsible for the generation of regulatory documents to support development and licensure and ensure regulatory compliance for gene therapy products in clinical development and commercial products.

We are currently recruiting for an Associate Director to join the team.  The purpose of this role is to support the development and execution of worldwide regulatory CMC strategies ensuring regulatory CMC compliance for gene therapy products in clinical development and commercial products, (pre- and post-approval).

Your responsibilities in this role would be:

• Proposing and developing regulatory strategies to meet pre-defined development milestones and goals
• Acting as key CMC regulatory contact and interface with external and internal clients and with global regulatory bodies
• Supporting product development teams in all aspects of regulatory CMC and provide input and authoring into relevant sections of development plans
• Responsible for the authoring, review and management of CMC regulatory documentation for filing to Regulatory Agencies (including Module 3/IND/IMPD)
• Authoring and coordinating the writing and generation of timely responses to questions from global Regulatory Agencies and external clients
• Preparing regulatory documentation for GMP inspections
• Providing regulatory CMC input and direction into Agency communications including preparation of briefing documents for scientific advice and using experience and know how in generating effective strategic resolutions
• Providing regulatory input into technical change controls in a timely manner

To be successful in this role, you will have the following skills and experience:

• Bachelor’s degree in a life science
• Extensive knowledge of regulatory CMC requirements including a comprehensive knowledge of biological and advanced medicinal products
• Experience with EU / US / ROW regulatory procedures and proven ability to write Regulatory CMC documentation
• Proven ability to work with regulatory bodies on the development of CMC and quality processes for biotech / high tech products
• Significant experience of Manufacturing, Quality Control/Assurance requirements for biotechnological products
• Good understanding of GMP regulations, preferably in the area of ATMPs
• Fluent in English, (spoken and written)

Do you want to feel inspired every day?  We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

Collaborate. Contribute. Change lives

No agencies please

Profile description:

Your responsibilities in this role would be:

• Proposing and developing regulatory strategies to meet pre-defined development milestones and goals
• Acting as key CMC regulatory contact and interface with external and internal clients and with global regulatory bodies
• Supporting product development teams in all aspects of regulatory CMC and provide input and authoring into relevant sections of development plans
• Responsible for the authoring, review and management of CMC regulatory documentation for filing to Regulatory Agencies (including Module 3/IND/IMPD)
• Authoring and coordinating the writing and generation of timely responses to questions from global Regulatory Agencies and external clients
• Preparing regulatory documentation for GMP inspections
• Providing regulatory CMC input and direction into Agency communications including preparation of briefing documents for scientific advice and using experience and know how in generating effective strategic resolutions
• Providing regulatory input into technical change controls in a timely manner

To be successful in this role, you will have the following skills and experience:

• Bachelor’s degree in a life science
• Extensive knowledge of regulatory CMC requirements including a comprehensive knowledge of biological and advanced medicinal products
• Experience with EU / US / ROW regulatory procedures and proven ability to write Regulatory CMC documentation
• Proven ability to work with regulatory bodies on the development of CMC and quality processes for biotech / high tech products
• Significant experience of Manufacturing, Quality Control/Assurance requirements for biotechnological products
• Good understanding of GMP regulations, preferably in the area of ATMPs
• Fluent in English, (spoken and written)

Do you want to feel inspired every day?  We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

Collaborate. Contribute. Change lives

No agencies please

We offer:

We are committed to offering highly competitive reward packages for all our staff. That’s why, every year, we benchmark our salaries and benefits against the local pharmaceutical market – by that, we mean that we compare our packages with those of other major companies in the London, Oxford, Cambridge areas.

We’re looking for highly skilled, focused individuals to help us deliver life-changing therapies to patients. It’s no mean feat, and we have to work together to make this happen.

Along the way, you’ll have a rich variety of opportunities to really develop your career. We’ll also give you a generous set of employee benefits and a competitive salary.