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 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
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