Regulatory Affairs Project Manager

X4 Group
£25k - 30k per year
12 Oct 2016
11 Nov 2016
Contract Type
Vacancy: Regulatory Affairs Project Manager Location: Hampshire Salary: £25,000- £30,000 (potential flexibility) An exciting Pharmaceutical Company based in Hampshire are currently looking for a Regulatory Affairs Project Manager to join their team on a permanent basis. The Regulatory Affairs Project Manager shall ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products. The Regulatory Affairs Project Manager will combine their knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a wide range of companies, meet the required legislation. Regulatory Affairs Project Manager Key Responsibilities: Ensuring that products comply with the required regulations of Drug Product and Medical Device in countries where the products are licensed. Compile, prepare, review and submit regulatory submission to authorities for Drug Products Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting. Collecting, collating and evaluating scientific data that has been researched by colleagues. Developing and writing clear arguments and explanations for new product licenses, variation and license renewals of Drug Product and Medical Devices. Preparing submissions of license variations and renewals to strict deadlines for national as well as MRP/DCP. Monitoring and setting timelines for license variations and renewal approvals. Writing clear, accessible product labels and patient information leaflets. Planning and developing product trials and interpreting trial data. Advising manufacturers on regulatory requirements. Providing strategic advice to senior management throughout the development of a new product. Project managing teams of colleagues involved with the development of new products. Undertaking and managing regulatory inspections. Reviewing company practices and providing advice on changes to systems. Liaising with and making presentations to cross-functional team, manufacturer and regulatory authorities. Negotiating with regulatory authorities for marketing authorization, variation and renewal application. Regulatory Affairs Project Manager Skills and Experience: Minimum 1-year experience with regulatory affairs project work within the pharmaceutical industry. Degree or equivalent in life sciences subject Work under pressure. Good written and spoken communication abilities. Being able to work with a team. Good problem solving abilities. Able to manage multiple priorities and projects and deadlines. If you believe you have the relevant skills and experience, please do not hesitate in sending an updated version of your CV to Matthew at X4 Group via or calling him on because interviews are being arranged from Friday 14th October onwards. Key Words: Regulatory Affairs/ RA/ CMC/ Variations/ MHRA/ RA Project Manager/ CE Mark This job was originally posted as