At a Glance
- Tasks: Lead regulatory strategy and submissions for vaccines, ensuring compliance and timely approvals.
- Company: Join Sanofi, a pioneering biopharma company at the forefront of drug discovery.
- Benefits: Flexible working options, comprehensive healthcare, and well-being programmes to support your growth.
- Other info: Diverse and inclusive workplace with opportunities for professional development and career advancement.
- Why this job: Make a real impact on global health by improving vaccine development and patient outcomes.
- Qualifications: 8-10 years in regulatory affairs with leadership experience and a life science degree.
The predicted salary is between 63000 - 77000 £ per year.
Location: Reading, UK
Working Pattern: 3 days onsite in Reading, 2 days remote per week
As Senior Regulatory Affairs Manager within our UK & Ireland Regulatory Affairs team, you'll lead regulatory strategy and submissions for our vaccines portfolio, managing the MHRA and HPRA lifecycle of marketing authorisations, leading the annual seasonal strain change process, and partnering with the Vaccines business and Global Regulatory Affairs to shape launches and registration plans, while leading and developing a small team.
Main Responsibilities:
- Lead the preparation, submission and follow-up of regulatory applications to UK and Irish health authorities, so that vaccine approvals are secured and kept up to date.
- Own the regulatory strategy for new approvals and ongoing changes, including support for product launches and the long-term management of the vaccine range.
- Lead the yearly seasonal flu vaccine update process, making sure UK and Irish submissions are on time and the vaccine supply stays compliant each season.
- Make sure all information sent to regulators is accurate, clearly presented and delivered on schedule.
- Build strong working relationships with the vaccines business and global regulatory colleagues, aligning regulatory plans with business priorities.
- Advise on how products are positioned and promoted, and contribute to commercial and operational planning from a regulatory angle.
- Coach, develop and manage a small team, setting clear priorities and supporting their growth, while also covering for the Head of Regulatory Affairs when needed.
About You:
- Minimum experience: 8–10+ years in regulatory affairs overall, including at least 3–5 years in a people-leadership capacity.
- Proven hands-on experience in UK regulatory affairs for biologics, including managing the lifecycle of a product portfolio (for example variations, renewals and submissions through national and European routes).
- A track record of leading and developing a team, with the ability to coach, motivate and set clear priorities.
- Sound judgement in handling manufacturing and supply changes, balancing regulatory compliance with business needs.
- Strong stakeholder management and communication, with the confidence to influence health authorities, business partners and cross-functional colleagues.
- A life science or chemistry degree, or equivalent practical experience in a related field.
- Fluent English, both written and spoken, as accurate communication is critical for regulatory submissions.
Why Choose Us:
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
- Accelerate your professional development with structured career paths designed for both scientific and leadership advancement.
- Grow in ways you never imagined through bold moves that stretch your potential, cross moves into other business areas, and short-term gigs that build your scientific expertise.
- Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.
- Achieve genuine work-life balance in a supportive R&D environment.
- Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive.
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, ability or gender identity.
Senior Regulatory Affairs Manager employer: Sanofi
Sanofi is an exceptional employer located in Reading, UK, offering a dynamic work culture that prioritises employee growth and well-being. With a strong focus on innovation and collaboration, employees benefit from a comprehensive rewards package, extensive health and wellness programs, and opportunities for career advancement both locally and internationally. Join a supportive team dedicated to making a meaningful impact in the field of medicine while enjoying a diverse and inclusive workplace.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Manager
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We think you need these skills to ace Senior Regulatory Affairs Manager
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Sanofi!
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Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Sanofi, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Sanofi
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Sanofi that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.