Senior Regulatory Executive

B&S Group ,
Ruislip, Greater London
More Details
Job Type: Full-time
Salary: £40,000 per annum

Overview

The B&S Group is a privately-owned pharmaceutical company which manufactures and distributes pharmaceutical and healthcare products to the UK market. Established in 1999 we offer a wide range of products and services which includes specials, generic drugs, branded medicines, parallel trade and over-the-counter (OTC) medicines. Having undergone two acquisitions since 2010, we are continuing to strengthen and grow. PRIMARY RESPONSIBILITIES Assist in the preparation and review of dossiers for MA applications (DCP, MR or national) and ensure timely submission of applications. Assist in the preparation and review of dossiers for MA variation applications, MA renewals and other regulatory submissions (DCP, MR or national) and ensure timely submission of applications Assist in the preparation and review of responses to requests for further information from regulatory authorities Prepare or review of national submission packages after the close of procedures Liaise with regulatory authorities when required Maintaining the product life cycle once the licence is approved. Responsible for the product approval package review and maintenance. Review of product information before product launch. Liaising with internal and external contacts to ensure that dossiers are prepared following the current best practice standards. To support the Regulatory Manager with SOPs, Change controls and review of internal processes. Keeping up-to-date with the current regulations/ guidelines and share the knowledge with the team. SECONDARY RESPONSIBILITIES Collaborate with internal departments for resolving any regulatory discrepancies. Creating and monitoring internal quality and non-quality changes through change control system. Proactively troubleshooting technical/quality issues relating to product preparations and submissions. To liaise with CROs to ensure clinical trials are conducted in accordance with the regulatory requirements. Liaise with contract manufacturers when required Providing regulatory support to the other departments Follow up with regulatory authorities on submissions and regulatory issues. Training of junior members of the Regulatory Department Involvement in review of third party dossiers when required ESSENTIAL Degree in life science subject with good knowledge of medicines and how they are used Well-developed regulatory experience in the pharmaceutical industry. Understanding of the drug development process. Good knowledge of EU directives, ICH guidelines. Ability to prepare high quality regulatory dossiers Ability to communicate effectively with regulatory authorities and other departments. Ability to handle multiple tasks in a fast-paced and constantly changing environment

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