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Regulatory Affairs ExecutiveRef: 24590TJB

Salary:£30000 - £35000 per annum + bonus and benefits

Added:13 Feb 2020

Region: London

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

An excellent opportunity has arisen for a Regulatory Executive to join a pharmaceutical company based in London. My client is a leading player in the UK generic pharmaceutical market with a strong portfolio and supply over 25 million prescriptions each year in the UK. The role: Our Regulatory Affairs department works across three sites on the full product life cycle including new marketing authorization applications, operational regulatory affairs activities, maintaining product information and communicating with regulatory authorities. We look to continuously expand our range of marketed products by carefully selecting molecules from our existing licences. This is why we are looking to expand our team of regulatory affairs professionals with a dynamic professional with good understanding of full life-cycle maintenance. Requirements: *You will have excellent project management skills and be able to prioritize and work to tight deadlines whilst driving the company's, department's and own objectives. *You are someone who wants to influence your own development. You are looking for a company where you broaden your experience and grow with the company. *You will be process driven with a can-do approach to find fitting and effective solutions to move projects forward. *You will be an experienced regulatory affairs professional who does not necessarily have full life-cycle management experience but is keen to learn, have a good eye for detail and good organizational skills. *You will be responsive to commercial requirements, dependable, reliable and have pride in your work. Responsibilities and accountabilities include: *Managing the full life cycle for the product group responsibility. *Effectively prepare submissions and regulatory documents including new MAAs, dossier sections and collate relevant information for CMC related variations. *Effectively prepare safety variations including the clinical review of SmPCs and subsequent updates to PILs. *Ensure accuracy, scientific validity and optimal presentation of submission documents. *Review product information and manage their implementation with contract manufacturers. *Identify regulatory issues and resolve with relevant parties. *Follow up with the authorities to ensure submissions are determined in a timely fashion. *Ensure the company working practices and operating procedures are followed. Required Experience: *Excellent working knowledge of the regulatory environment and the ability to communicate effectively with regulatory agencies within the EU. *Have a broad regulatory background encompassing a variety of therapeutic areas. *Have excellent written and oral communications skills to communicate clearly and effectively with third parties, regulatory authorities and management. *A strong track record in regulatory affairs. *Proven strengths in attention to detail, analytical ability, understanding and interpreting regulations. *Ability to plan, prioritize and work in a team. *Proven regulatory affairs experience, including demonstrated knowledge and expertise in post-approval MA maintenance (including both product labelling and CMC activities). *Prior and recent experience of direct interactions with the MHRA. *A sound understanding of current EU regulations and a good insight into national, MRP and DCP licensing procedures. *A life sciences or chemistry Degree to honours level or equivalent. For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk

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