about 1 month ago
Job title: Associate Director, Regulatory Affairs
A global pharmaceutical business in London is seeking an Associate Director to join their team. This role will be responsible for handling all regulatory activities for phase one and two clinical trials. The ideal candidate will have significant early-stage clinical development experience as well as the ability to communicate effectively across the business.
- Define and develop regulatory strategies for projects, particularly focussing on early development up to clinical proof of concept.
- Lead planning, preparation, and submission of regulatory submissions for EU for example Clinical Trials Authorisations, Orphan Drug Designations, and Paediatric Investigations Plans.
- Lead communications with EU Health Authorities, including scientific advice meetings with EMA and/or EU Competent Authorities.
- To maintain detailed working knowledge of the regulatory environment, through direct and indirect contact and relationship with agencies and industry groups.
- Extensive regulatory experience within the pharmaceutical industry, ideally in EU and global regulations.
- Must have full understanding of the drug development process and where and how regulatory aspects fit into that.
- An excellent communicator.
- A life sciences degree would be beneficial.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer
To apply for this position or hear further details then please contact Freddie Hill via Freddie.email@example.com