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Associate Director Regulatory Affairs - Oncology

Central London   •  Negotiable  •  Permanent, Full time


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

Permanent position

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.

Responsibilities include.

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.

Requirements

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.harris@cpl.com.

  • Agency: Cpl Life Sciences
  • Reference: JO-2207-497173
  • Posted: 19th July 2022
  • Expires: 16th August 2022

Cpl Life Sciences

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