Job Description


Life Cycle Management, Regulatory Affairs Manager

£60,000 - £75,000 Per Annum
Job Requirements/Description
Job Title: Regulatory Affairs Managers, Life Cycle Management BPS are currently recruiting for a Regulatory Affairs Manager, Life Cycle Management for a permanent position based in Maidenhead, working for a pharmaceuticals manufacturing company. This position is responsible for post approval changes of Marketing Authorisations, and product life cycle management. Responsibilities will include: * Accountable for management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations like variations, notifications, labelling updates, renewals, sunset clause etc across product portfolio. * Maintenance of MIA and WDA including API import registration. * Filing strategy and managing submission timelines. * Identifying and remediating compliance gaps if any. * Gather, consolidate, analyse documentation and submit regulatory filings. * Coordinate and prepare written responses to requests for information from regulatory authorities. * Monitor status of regulatory applications. * Review and assess the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product. * Provide product & regulatory expertise and clarification on RA requirements for post marketing changes and new product introduction. * Provide regulatory support to supply chain, commercial teams, QP, QPPV, Quality 3rd Party contract management as necessary. * Contribute to the creation, maintenance and continuous improvement of Regulatory processes, policies and systems. * Maintain up to date knowledge of Regulatory and Quality Management requirements, as needed to support the contract manufacture of current products and the introduction of new products. * Build good working relationship with CMOs and cross functional teams within the organisation. * Supervise assigned team members with respect to management and training. Skills & Requirements: * Understanding of GMP, Quality and Regulatory requirements. * Communicative and able to work with a range of stakeholders, at all levels, both internally and externally. * Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools. * Maintaining an awareness changing regulatory requirements. To learn more about this role please click "apply" with an up to date copy of your CV and Peter Harding @ BPS World will be straight in touch with you
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