Pharmaceutical Regulatory Affairs Specialist - Part- time

A Pharmaceutical Regulatory Affairs Specialist is required with current/recent clinical trials experience.

The role has responsibility for a number of regulatory activities, across the lifecycle of the pharmaceutical drug product portfolio, which includes diverse products from small molecules to biologicals.

Hours per week: 7.4 hours per week

Contract Length: Anticipated 24 months

Location: London/Remote - predominantly remote working with the expectation to attend meetings as required.

*This role will sponsor SC Clearance*

Key responsibilities:

• Prepare and drive regulatory drug development plans for each product to ensure seamless transition between development phases to meet UK regulatory requirements.
• Work with technical teams to ensure robust studies are planned, carried out to the required regulatory standards and reported appropriately.
• Manage and conduct interactions with external regulatory authorities.
• Support preparation of documents such as Target Product Profiles (TPPs), Investigator’s Brochures (IBs) and Investigational Medicinal Product Dossiers (IMPDs).
• Manage Clinical Trial Applications (CTAs) and related activities.

Key requirements:

• Demonstrable experience of regulatory affairs experience in drug development .
• A good working knowledge of current UK regulatory guidelines and regulations.
• A good working knowledge of the drug development lifecycle.
• A good working knowledge of GCP.
• Demonstrable experience of contributing to the preparation of TPPs, IBs and IMPDs.
• Demonstrable experience of managing CTAs.
• Demonstrable experience of interactions with regulatory authorities.
• Can demonstrate maintenance of currency in regulations and requirements affecting pharmaceutical product development activities.

If you consider yourself to have a disability or if you are a veteran, and you meet the essential criteria for the role, you will be put forward for the ‘Guaranteed Interview’ scheme whereby you will have the opportunity to discuss this role and your suitability with a member of the Sourcing team.

If you are successful in securing this role, please note that for the entire duration of this contract, regardless of extension you will be working this role at the equivalent PAYE rate that has been advertised. For absolute clarity, we only work on a PAYE basis. If you wish to understand PAYE vs Umbrella more, please let us know and we can send you some additional information.