Junior 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.
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
- Life sciences or chemistry degree or equivalent professional qualification
- Experience in the pharmaceutical industry desirable, not essential
- The following competencies would be developed through internal training:
- 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 CMC changes and the ability to identify changes to registered details
- An awareness of ABPI and IPHA code, promotional and non-promotional materials and PI
- An awareness of reporting procedures for notifying Health Authorities (UK/IE) in case of out of stock
- Awareness of the Common Technical Document (CTD) and pharmaceutical dossier structure
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.
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 diversity.recruitmentUKIE@sanofi.com. 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.
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.
#J-18808-Ljbffr…