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- Tasks: Lead regulatory strategies for gene therapy products and ensure compliance with global standards.
- Company: Join a pioneering company dedicated to using science to save lives.
- Benefits: Enjoy flexible working arrangements, competitive rewards, and wellbeing programmes.
- Why this job: Be part of a passionate team making a real impact in healthcare.
- Qualifications: Bachelor’s in life sciences with CMC regulatory experience and knowledge of GMP regulations.
- Other info: Work in state-of-the-art facilities within a diverse and inclusive environment.
The predicted salary is between 48000 - 72000 £ per year.
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 to develop 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 consider flexible home working arrangements combined with some on-site presence.
Your responsibilities in this role would be:
- Act as key CMC regulatory contact and interface with external and internal clients and 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:
- Highly competitive total reward packages.
- Wellbeing programmes.
- Development opportunities.
- 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. Collaborate. Contribute. Change lives.
Director Regulatory Science- CMC employer: OXB
Contact Detail:
OXB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Regulatory Science- CMC
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines and updates in CMC for gene therapy products. This knowledge will not only help you during interviews but also demonstrate your commitment to staying current in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory science community, especially those who have experience with EU and US regulatory procedures. Attend industry conferences or webinars to make connections that could lead to valuable insights and potential referrals.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with regulatory documentation and interactions with regulatory bodies. Being able to articulate your successes and challenges will showcase your expertise and problem-solving skills.
✨Tip Number 4
Demonstrate your client-centric approach by thinking of ways to enhance client relationships and improve communication strategies. Highlighting this mindset can set you apart as a candidate who aligns with our values at StudySmarter.
We think you need these skills to ace Director Regulatory Science- CMC
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the Director Regulatory Science - CMC position. Tailor your application to highlight relevant experiences that align with the job description.
Highlight Relevant Experience: In your CV and cover letter, emphasise your specific regulatory experience in biological and advanced therapy products. Mention any direct interactions with EU and US regulatory bodies and your proven record of writing regulatory CMC documentation.
Showcase Your Skills: Demonstrate your understanding of GMP regulations and regulatory guidelines affecting quality, manufacturing, and controls. Use specific examples from your past work to illustrate your ability to manage multiple projects and meet tight deadlines.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also reflects your passion for the role and the company's mission. Make sure to convey how you embody their values of being responsible, responsive, resilient, and respectful.
How to prepare for a job interview at OXB
✨Understand Regulatory Frameworks
Familiarise yourself with the regulatory frameworks specific to CMC, especially in relation to gene therapy products. Be prepared to discuss your experience with EU and US regulatory procedures, as well as any relevant guidelines affecting quality and manufacturing.
✨Showcase Your Documentation Skills
Highlight your experience in writing and managing CMC regulatory documentation. Be ready to provide examples of past projects where you successfully authored or reviewed submissions, such as Module 3/IND/IMPD documents.
✨Demonstrate Client-Centric Approach
Emphasise your ability to work collaboratively with both internal teams and external clients. Share instances where you developed regulatory strategies that met client needs and project milestones, showcasing your client-centric mindset.
✨Prepare for Technical Questions
Anticipate questions related to GMP regulations and how they apply to advanced therapy medicinal products (ATMPs). Be ready to discuss how you have handled technical change controls and deviations in previous roles.
