Reference Number: JO-2207-497173
Associate Director Regulatory Affairs – Oncology
Job Type: Permanent
Location: Central London / West End
Regulatory Affairs Associate Director, Oncology
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-2207-497173
CPL Life Sciences collaborating with a pharmaceutical business 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 oncology products 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.
Leadingthe 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 dont hesitate to contact me on Charlie.firstname.lastname@example.org.