Reference Number: JO-2203-487937_2
Associate Director Regulatory Affairs
Job Type: Permanent
Regulatory Affairs Associate Director, CAR T-Cell Therapy
Location: South England, flexible to offer up to 3 days home working
Salary: Up to £100,000 per annum + car allowance and other benefits
Job Reference: JO-2203-487937
CPL Life Sciences collaborating with a pharmaceutical business specialized in CAR T-Cell Therapies to hire an experienced Regulatory Associate Director. In this role, you will be responsible for leading interactions with the health authorities and will take ownership of products in development as well as post-marketing, globally. The correct applicant for this role must have worked with innovative products and be comfortable working in a problem-solving environment. There are no requirements to have prior experience working with ATMPs, so this could be an incredible opportunity to get into this field, but you must have worked with innovative pharmaceutical products & submitted applications to the EMA via the centralized procedure.
· Leading the preparation of key regulatory documents (e.g. MAAs, CHMP Scientific Advice, PIPs)
· Taking the lead on a major extension indication
· Preparing and leading scientific advice meetings with relevant health authorities
· Developing and implementing regulatory strategies
· Manage a junior employee to support products in the development and post-marketing stages.
· 9+ years’ experience working within Regulatory Affairs.
· Experience working with advanced therapies or oncology products is highly advantageous but not essential
· Must have worked with centralized procedure application.
· Must have a technical and strategic mindset.
· Must be experienced working with clinical development activities – scientific advice, PIPs, ODDs
If you are interested in discussing this role or any of our other active positions, please don’t hesitate to contact me on Chris.Bart@cpl.com