Pharmaceutical Regulatory Affairs Specialist

This contract with our defence client is for a Pharmaceutical Regulatory Affairs Specialist for 2 years. The role is located in Porton Down and hybrid working is available. Occasional travel to London may be required .  

Job Description:  

The requirement is for a Pharmaceutical Regulatory Affairs Specialist to join a small, busy, multifunctional team of pharmaceutical development staff and Project Managers. The role has responsibility for a number of regulatory activities, across the lifecycle of the company pharmaceutical 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 development plans for each product to ensure seamless transition between development phases  

• 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  

• Preparing and managing regulatory documents such as Target Product Profiles (TPPs), Investigator’s Brochures (IBs), Investigational Medicinal Product Dossiers (IMPDs) and developmental risk management plan (DRMP)  

• Preparing and managing Clinical Trial Applications (CTAs) and related supporting activities  

• Assisting in building electronic document structures to aid future eCTD compilation  

• Supporting the production of Marketing Authorisation applications (externally delivered)  

• Maintaining regulatory intelligence and updating project teams  

• Supporting and implementing regulatory aspects of organisational quality systems

• Demonstrable experience in regulatory affairs experience in pharmaceutical development (pharmaceutical company or CRO)  

• A good working knowledge of current regulatory guidelines and regulations  

• A good working knowledge of the pharmaceutical development lifecycle  

• A good working knowledge of GCP –) Good clinical practise)  

• Demonstrable experience of contributing to/preparing TPPs (Target product Profile), IBs (Inves-tigator Brochure) and IMPDs (Investigational Medicinal Product Dossiers)  

• Demonstrable experience of preparing and/or managing CTAs (Clinical Trial Applications)  

• Demonstrable experience of interactions with Regulatory Authorities  

• Demonstrable experience of applying/constructing CTD (Common Technical Dossiers) document structures for pharmaceutical development projects to support MAAs (Marketing Authorisation Application)  

• Maintain currency in regulatory affairs regulations and requirements affecting pharmaceutical product development activities  

Desirable:  

• Working knowledge of GMP (Good manufacturing practise) and GLP (Good laboratory practise)  

• Experience of writing summary reports for regulatory submissions  

• An understanding of pharmaceutical regulations in other countries/regions e.g., US FDA  

• Higher qualification in a pharmaceutical related field  

Previous role titles:  

• Regulatory Manager  

• Regulatory Officer  

• Pharmaceutical Regulatory Affairs Specialist  

Essential - Degree in a science discipline OR equivalent  

Desirable - Higher qualification in pharmaceutical related field