Associate Director, Regulatory Science, CMC

OXB; England; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

A biopharmaceutical company in the UK seeks an Associate Director to develop and execute regulatory CMC strategies for gene therapy products. You will interface with clients and regulatory bodies, write documentation, and ensure compliance. The ideal candidate has a life sciences degree and CMC regulatory experience. The company offers competitive rewards, development opportunities, and a supportive work environment with flexible arrangements.

Benefits

Highly competitive total reward packages

Wellbeing programmes

Development opportunities

Supportive colleagues

Diverse working environment

Qualifications

• Direct experience with regulatory procedures and writing documentation.
• Experience of interactions with regulatory bodies.
• Comprehensive knowledge of regulatory guidelines for biological products.

Responsibilities

• Act as key regulatory contact with clients and regulatory bodies.
• Propose and develop regulatory strategies.
• Write and manage CMC regulatory documentation.

Skills

CMC specific regulatory experience

Experience with EU and US regulatory procedures

Good understanding of GMP regulations

Client centric self-starter

Education

Bachelor’s degree in a life science

Job description

Overview

We use science to save lives, and so can you.

We are currently recruiting for an Associate 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.

Responsibilities

• 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.

Qualifications

• 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

LI-REMOTE