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- Tasks: Lead regulatory strategies for gene therapy products and ensure compliance with global standards.
- Company: Join Oxford BioMedica, a pioneer in cell and gene therapy with over 25 years of experience.
- Benefits: Enjoy flexible working arrangements, competitive rewards, and a supportive, inclusive environment.
- Why this job: Be part of a mission-driven team that saves lives through innovative therapies and collaboration.
- Qualifications: Bachelor’s in life sciences with CMC regulatory experience in biological or advanced therapy products.
- Other info: Work in state-of-the-art facilities and thrive in a culture of passion and teamwork.
The predicted salary is between 72000 - 108000 £ per year.
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Director Regulatory Science- CMC, Oxford
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Client:
Oxford BioMedica
Location:
Oxford, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
702c66ddcab2
Job Views:
6
Posted:
12.07.2025
Expiry Date:
26.08.2025
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Job Description:
We use science to save lives, and so can you.
We are currently recruiting for a Director, Regulatory Science CMC team. The purpose of this role is todevelop and execute worldwide regulatory CMC strategies with our clients and to ensure regulatory CMC compliance for clinical development and commercial gene therapy products.
We are happy to considerflexible home working arrangementscombined with some on-site presence.
Your responsibilities in this role would be:
- Act as key CMC regulatory contact and interface with external and internal clientsand with global regulatory bodies.
- Propose and develop regulatory strategies with internal and external clients to meet pre-defined development milestones and goals.
- Write, review and manage CMC regulatory documentation for filing to regulatory agencies (including Module 3/IND/IMPD/ Quality Overviews).
- Coordinate and author CMC/quality responses to questions from regulatory agencies and external clients.
- Provide regulatory CMC input and direction into Agency communications including preparation of briefing documents for scientific advice and support / attendance at client Agency advice meetings.
- Provide regulatory review and sign off for technical change control and deviations in a timely manner.
- Support regulatory intelligence activities to ensure ongoing regulatory compliance.
We are looking for:
- Bachelor’s degree in a life science
- CMC specific regulatory experience in the areas of biological and/or advanced therapy products
- Direct experience with EU and US regulatory procedures and proven record of writing regulatory CMC documentation
- Experience of interactions with regulatory bodies
- Good understanding of GMP regulations, preferably in the area of ATMPs
- Comprehensive knowledge of regulatory guidelines affecting the quality, manufacturing and controls of biological and advanced therapy products.
- A client centric self-starter, able to work to tight deadlines with the ability to balance multiple projects and priorities
What’s in it for you:
OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.
OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.
What’s in it for you:
- Highly competitive total reward packages
- Welcoming, friendly, supportive colleagues
- A diverse and inclusive working environment
- Our values are: Responsible, Responsive, Resilient, Respect
- State of the art laboratory and manufacturing facilities
We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.
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Director Regulatory Science- CMC employer: Oxford Biomedica
Contact Detail:
Oxford Biomedica Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Regulatory Science- CMC
✨Tip Number 1
Network with professionals in the regulatory science field, especially those who have experience with CMC and gene therapy products. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 2
Familiarise yourself with the specific regulatory guidelines and compliance requirements for biological and advanced therapy products. This knowledge will not only help you in interviews but also demonstrate your commitment to understanding the role's demands.
✨Tip Number 3
Prepare to discuss your direct experiences with EU and US regulatory procedures during interviews. Be ready to share specific examples of how you've successfully navigated these processes in previous roles, as this will highlight your expertise and suitability for the position.
✨Tip Number 4
Showcase your ability to work under tight deadlines and manage multiple projects by providing examples from your past work. Highlighting your organisational skills and client-centric approach will resonate well with the values of the company.
We think you need these skills to ace Director Regulatory Science- CMC
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Director Regulatory Science- CMC position. Make sure you understand the responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your specific experience in regulatory CMC, particularly with biological and advanced therapy products. Mention any direct interactions with EU and US regulatory bodies to showcase your expertise.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for the role and the company’s mission. Use specific examples from your past work to illustrate how you can contribute to their goals.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory roles.
How to prepare for a job interview at Oxford Biomedica
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the regulatory frameworks relevant to CMC, especially in the context of biological and advanced therapy products. Familiarise yourself with EU and US procedures, as well as GMP regulations, to demonstrate your expertise during the interview.
✨Showcase Your Experience
Prepare to discuss your direct experience with writing regulatory CMC documentation and your interactions with regulatory bodies. Be ready to provide specific examples of how you've successfully navigated complex regulatory challenges in the past.
✨Highlight Client-Centric Approach
Since the role requires a client-centric mindset, think of instances where you've effectively collaborated with clients to develop regulatory strategies. Emphasise your ability to balance multiple projects while maintaining strong client relationships.
✨Prepare for Technical Questions
Expect technical questions related to CMC documentation and regulatory compliance. Brush up on your knowledge of Module 3/IND/IMPD submissions and be prepared to discuss how you would handle regulatory queries or deviations in a timely manner.
