Regulatory Affairs Officer

Job Purpose: To obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. To conduct associated regulatory activities for the specified markets under the guidance and supervision of line management, and to contribute to the implementation and leading of projects.

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• Co-ordinates, prepares, submits and follows up registration applications to the UK and /or Irish regulatory authorities, expeditiously and to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company's plans and goals.
• Prepares and submits responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed, under supervision, to facilitate the earliest possible approval.
• Prepares and reviews labelling, package leaflets and summaries of product characteristics etc. to ensure compliance with current legislation and registered particulars, and takes action, as agreed with supervisor, to secure regulatory approval where necessary.
• Supports the launch of new products and life cycle management of the existing portfolio.
• In order to achieve success, it is essential that the Regulatory Officer:
• 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 deadlines.
• 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 and operating planning processes for commercialisation of products, both locally and in conjunction with GRA.
• 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.

• At least 1 year experience working in Regulatory Affairs, preferably up to 2 years.
• An understanding of lifecycle maintenance for pharmaceutical products, particularly variations.
• Proven project management skills.
• Biologicals and/or Vaccines experience desirable.
• Life sciences or chemistry degree or equivalent professional qualification or proven relevant experience within the regulatory environment.
• Proven familiarity with the pharmaceutical research and development process with ability to 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.
• An awareness of EU regulatory procedures for marketing authorisations and submission to regulatory authorities.
• An awareness of lifecycle maintenance for pharmaceutical products, including variations and renewals.
• An awareness of ABPI and IPHA code, promotional and non-promotional materials and PI.
• Awareness of product quality and Good Manufacturing Practice (GMP) requirements.
• An understanding of CMC changes and the ability to identify changes to registered details.
• An understanding of the Common Technical Document (CTD) and pharmaceutical dossier structure.
• Administratively well organised, demonstrating attention to detail, strong written and oral communication skills. Able to communicate effectively and efficiently with other functional departments in the business.

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
• Join us in shaping the future of respiratory care and making a difference in the lives of patients across the NHS.

• If you have a disability and require adjustments for the interview process, please email us at . We are dedicated to ensuring an inclusive and supportive experience for all applicants.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!