Pharmaceutical Regulatory Affairs Specialist
Quote ref: 990036/74489
This contract with our central government client is for a Pharmaceutical Regulatory Affairs Specialist for 24 months 7.4 hours a week- this can be split across the week. The role is hybrid, predominantly remote with some need to attend meetings in Porton Down and London. The pay rate is £93.85 UMB £69 PAYE per hour.
The requirement is for a Pharmaceutical Regulatory Affairs Specialist to join a small, busy, multifunctional team of pharmaceutical drug development staff and Project Managers. 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. The successful candidate will work closely with Project Managers and project development teams in supporting the following range of activities:
• Preparing and driving regulatory drug development plans for each product to ensure seamless transition between development phases to meet UK regulatory requirements.
• Working with technical teams to ensure robust studies are planned, carried out to the required regulatory standards and reported appropriately
• Managing and conducting interactions with external regulatory authorities, primarily the MHRA.
• Supporting preparation of documents such as Target Product Profiles (TPPs), Investigator’s Brochures (IBs) and Investigational Medicinal Product Dossiers (IMPDs)
• Managing Clinical Trial Applications (CTAs) and related activities
• Assisting in building electronic document structures to aid future eCTD compilation
• Maintaining regulatory intelligence and updating project teams
• Supporting and implementing regulatory aspects of organisational quality systems
• Demonstrable experience of regulatory affairs experience in drug development (pharmaceutical company or CRO)
• 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
• Working knowledge of GMP and GLP
• An understanding of pharmaceutical regulations in other countries/regions, e.g. US, EU
• Higher qualification in a pharmaceutical related field
• Demonstrable experience of structuring and preparing CTD documents for MAAs