Regulatory Affairs Officer
- Location: Reading
- Hybrid work: 3 days based onsite in Reading
About the job
As a Regulatory Affairs Officer you will obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. You will be responsible for conducting associated Regulatory activities for the specified markets under the guidance and supervision of line management and will contribute to the implementation and leading of projects.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main responsibilities
- Co-ordinate, prepare, submit and follow 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.
- Assist and provide support in the preparation, distribution and follow up of registration documentation required for UK and Ireland.
- Ensure 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.
- Work proactively with members of the Global Business Units and other Global functions to ensure project needs are met compliantly within agreed timelines.
- Assist management in providing strategic input into the development of registration strategies and operating planning processes for commercialisation of products, both locally and in conjunction with Global Regulatory Affairs (GRA).
- Contribute to the effective running of departmental and cross-functional project teams.
- Support activities to obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. Conduct associated Regulatory activities for the specified markets under the guidance and supervision of line management and contribute to the implementation and leading of projects.
- Provide Regulatory input, with support, to commercial strategic and operating planning process.
About you
- Proven Regulatory Affairs experience in the pharmaceutical industry is required.
- 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 reporting procedures for notifying Health Authorities (UK/IE) in case of out-of-stock.
- Awareness of product quality and Good Manufacturing Practice (GMP) requirements.
- 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.
Why choose us
- 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.
Disability Confident Employer
We are proud to be a Disability Confident Employer, committed to offering interviews to candidates who request consideration under the Scheme and meet the minimum requirements for this role. 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.
Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources.
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.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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