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For Companies At a Glance
- Tasks: Manage product Marketing Authorisations and conduct regulatory activities in a dynamic healthcare environment.
- Company: Join an innovative global healthcare company dedicated to improving lives through science.
- Benefits: Enjoy hybrid work, health benefits, and generous parental leave in a supportive culture.
- Why this job: Be part of a team that values growth, collaboration, and making a real impact.
- Qualifications: A degree in life sciences or chemistry and experience in regulatory affairs are essential.
- Other info: We are committed to inclusivity and offer support for candidates with disabilities.
The predicted salary is between 28800 - 43200 £ per year.
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/orIrish 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.
Pursue Progress. Discover Extraordinary.
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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
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 !
#LI-EUR
#LI-HYBRID
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 !
#J-18808-Ljbffr
Regulatory Affairs Officer employer: Sanofi
Contact Detail:
Sanofi Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks in the UK and Ireland. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who work in pharmaceutical companies. Attend industry events or join relevant online forums to make connections that could lead to valuable insights and potential referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory affairs by following industry news and publications. This knowledge can give you an edge during discussions and show that you are proactive about your professional development.
✨Tip Number 4
Prepare to discuss specific projects or experiences where you've successfully navigated regulatory challenges. Being able to share concrete examples will highlight your expertise and problem-solving skills, making you a more attractive candidate.
We think you need these skills to ace Regulatory Affairs Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Regulatory Affairs, particularly within the pharmaceutical industry. Emphasise any specific projects or roles that align with the responsibilities mentioned in the job description.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for the role and the company. Mention how your background in life sciences or chemistry makes you a suitable candidate for the position.
Highlight Key Skills: In your application, focus on key skills such as attention to detail, strong communication abilities, and familiarity with EU Regulatory procedures. Use specific examples to illustrate how you've successfully applied these skills in past roles.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Ensure there are no spelling or grammatical errors, and that all information is clear and concise. A polished application reflects your professionalism and attention to detail.
How to prepare for a job interview at Sanofi
✨Know Your Regulatory Affairs Basics
Make sure you brush up on your knowledge of EU regulatory procedures and marketing authorisations. Being able to discuss these topics confidently will show that you understand the core responsibilities of a Regulatory Affairs Officer.
✨Demonstrate Attention to Detail
Since the role requires high-quality data submission, be prepared to showcase your attention to detail. You might be asked about past experiences where your meticulousness made a difference in a project or application.
✨Prepare for Scenario-Based Questions
Expect questions that assess how you would handle specific regulatory challenges. Think of examples from your previous experience where you successfully navigated complex regulatory environments or resolved issues with authorities.
✨Showcase Your Communication Skills
As the role involves working with various teams, highlight your ability to communicate effectively across departments. Be ready to provide examples of how you've collaborated with others to achieve regulatory goals.
