This is a fully remote opportunity to join an rapidly growing and reputable Biotech company in the Cell and Gene Therapy space.
They are seeking a Senior Regulatory Affairs Manager, experienced in biologic clinical trial applications across UK/EU and, US experience is a bonus.
Responsibilities:
* Planning, coordination, preparation, review and submission of regulatory applications and submissions.
* You will be responsible for assigned clinical studies including trial documentation, review and planning submissions.
* Coordinate, review and respond to queries from regulatory agencies.
* Support maintenance and approval of drug applications to the regulatory agencies throughout the whole lifecycle of the product.
* Ensure correct procedures are followed relating to advanced medicinal therapy products.
* Keep up to date with Cell & Gene therapy regulatory intelligence.
Requirements:
* 6-8 years of experience within the biotech and/or a pharmaceutical sector within regulatory affairs
* Proven experience in completing and submitting clinical trial applications in Europe, preferably Europe and United States.
* Experience the planning, coordination and execution of Scientific Advice or other regulatory agency meetings.
* Having experience in other key areas of the product lifecycle, such as, marketing authorisation applications (MAA's)
* Scientific and regulatory writing skills.
* Strong communication skills.
* Ability to work remotely and autonomously.