associate director/senior manager regulatory affairs

**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 Biomedicas Regulatory team is responsible for developing and executing worldwide regulatory strategies for advanced therapy medicinal products across a number of therapeutic areas.

We are currently recruiting for an Associate Director/Senior Manager to join the regulatory CMC team. The purpose of this role is to support the development and execution of worldwide regulatory CMC strategies for both external clients and internal development teams, ensuring regulatory CMC compliance for advanced therapy medicinal products in both clinical development and commercial phases

 **Your responsibilities in this role would be:** 


* Proposing and developing regulatory strategies to meet pre-defined development milestones and goals
* Acting as key regulatory CMC contact and interface with external and internal clients
* Supporting product development teams in all aspects of regulatory CMC and provide input into relevant sections of development plans
* Assisting in the authoring, review and management of regulatory CMC documentation for filing to Regulatory Agencies (including Module 3/IND/IMPD)
* Coordinating and providing input into responses to questions from Regulatory Agencies and external clients
* Assisting in preparing regulatory documentation for GMP inspections
* Assisting in providing regulatory CMC input into Agency communications including preparation of briefing documents for scientific advice
* Providing regulatory input into technical change controls and deviations in a timely manner

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


* Bachelors degree in a life science
* Extensive CMC- specific regulatory knowledge and experience (EU/US/ICH and other relevant guidance)
* Experience with EU and US regulatory procedures and proven ability to write Regulatory CMC documentation with excellent attention to detail
* Experience of working with both FDA and EMA on the development of CMC and quality processes for biotech / high tech products
* Good understanding of GMP regulations, preferably in the area of ATMPs
* An understanding of global regulatory requirements would be an advantage
* Fluent in English (spoken and written)

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

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