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Senior Regulatory Affairs Officer

Zoek Pin - Reading - This Area Only

Competitive

Permanent (Full time)

Job Description

Senior Regulatory Affairs Officer Based Reading, Berkshire About the Opportunity Based from our prestigious facility on the Thames Valley Business Park, we have an exciting opportunity available to join our Regulatory team where you will obtain, manage and maintain product marketing authorisations in line with business goals and legal requirements. You will lead the implementation of projects and mentor/coach junior members of the team. If you are a Regulatory Affairs professional and would like to join us and make a difference, please apply! Key Responsibilities: * Ensures that all data supplied to the regulatory authorities are of the highest quality possible in terms of both content and presentation, whilst meeting agreed deadline * Works proactively with members of the Global Business Units and other Global functions to ensure project needs are met compliantly within agreed timelines * Assists management in providing strategic input into development of registration strategies for commercialisation of products, both locally and in conjunction with GRA * Inputs into review of promotional and non-promotional materials from a regulatory perspective, as required * Contributes to the effective running of departmental and cross functional project teams * Supports activities to obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. Conducts associated regulatory activities for the specified markets under the guidance and supervision of line management and contributes to the implementation and leading of projects * Provides regulatory input, with support, to commercial strategic and operating planning process * Provides mentoring/coaching to junior regulatory team members and student placements, assisting in supervision and training as required * Deputises for Manager/Senior Manager roles, where sufficient experience has been gained, as required About You: To excel in this role, you will need to have: * Life sciences or chemistry degree or equivalent professional qualification or proven relevant experience within the regulatory environment * Additional experience in the pharmaceutical industry or a related field desirable * Proven familiarity with the pharmaceutical research and development process with ability to critically review and integrate scientific information from a variety of disciplines * Ability to work across a variety of therapeutic areas with new and/or established medicines with the capability to represent Regulatory at brand meetings, with support from management * A comprehensive understanding of EU regulatory procedures for marketing authorisations and submission to regulatory authorities * Significant post-licencing experience with an understanding of lifecycle maintenance for pharmaceutical products, including variations and renewals * An awareness of post-Brexit procedural routes to UK national marketing authorisation * Knowledge/understanding of ABPI and IPHA code, promotional and non-promotional materials and PI * Understanding of the Common Technical Document (CTD) and pharmaceutical dossier structure * Familiarity with electronic submission platforms and electronic publishing * Understanding of product quality and Good Manufacturing Practice (GMP) requirements * A basic understanding of clinical trials and clinical development of new medicines * Previous experience of working with orphan medicinal products is desirable * Experience of EU Centralised Procedures and agency submission to the EMA * An understanding of biosimilars and medical devices is desirable What Sanofi can offer you: * A role where you are instrumental to creating best practice and as the organisation grows, you can too * We offer a generous package including flexible benefits and are committed to helping you have a healthy work-life balance throughout your career with us * We are based in Reading, Thames Valley Park and support flexible working Thank you for your interest in Sanofi and we look forward to hearing from you! About Sanofi Empower Life Everyday At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be. Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we're not there to try to solve everybody's problems. We want to focus on those areas where we know we are making a difference. The values we are live by are teamwork, courage, respect and integrity. LI-EUR At Sanofi diversity and inclusion is foundational to how we operate and

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