Overview
Associate Director, Regulatory Science, CMC – Location: Oxford, GB • Company: oxfordbiom
We are currently recruiting for the Associate Director, Regulatory Science CMC role. 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
Additional information
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Research, Analyst, and Information Technology
* Industries: Pharmaceutical Manufacturing
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