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- Tasks: Lead regulatory affairs for OTC products, vitamins, and supplements in the UK.
- Company: Join Sanofi, a global leader in healthcare committed to progress and diversity.
- Benefits: Enjoy a hybrid work arrangement and a culture of inclusion and equal opportunities.
- Why this job: Shape the regulatory landscape while ensuring compliance and driving innovation.
- Qualifications: University degree required; knowledge of UK regulatory affairs and CHC regulations preferred.
- Other info: Additional language skills are a plus; strong teamwork skills needed.
The predicted salary is between 43200 - 72000 £ per year.
Regulatory Affairs Manager page is loaded
Regulatory Affairs Manager
Apply locations Reading time type Full time posted on Posted Yesterday time left to apply End Date: March 1, 2025 (29 days left to apply) job requisition id R2775678
Regulatory Affairs Lead UK at Sanofi (specifically for their Opella business unit). This role involves overseeing the regulatory affairs for the Consumer Healthcare (CHC) portfolio, focusing on OTC products, vitamins, and supplements in the UK. The responsibilities include:
Key Responsibilities:
Portfolio Management:
- Preparing and managing marketing authorization applications.
- Ensuring product labels, leaflets, and summaries are compliant with regulations.
- Overseeing product packaging to meet regulations.
- Reviewing promotional materials for compliance.
- Managing OTC switches and local regulatory strategies.
Regulatory Compliance:
- Keeping product packaging and information up to date in line with current licenses.
- Implementing mandatory SOPs and ensuring regulatory compliance across the organization.
Regulatory Environment Influence:
- Tracking and responding to emerging regulatory changes.
- Participating in local trade associations and influencing the regulatory landscape.
- Building relationships with health authorities to support the company’s strategy.
Innovation and Risk Management:
- Contributing to innovation programs and identifying regulatory risks.
- Overseeing the approval of risk management plans and related materials.
About You:
- A university scientific degree is required.
- Knowledge of UK and international regulatory affairs and CHC regulations .
- Experience with regulatory aspects of medicines, food supplements, and medical devices.
- Strong matrix team working skills and ability to drive regulatory excellence.
- Additional language skills would be a plus.
Company Culture and Benefits:
Sanofi highlights its commitment to progress, diversity, and inclusion, offering equal opportunities for all candidates. The role is based in Reading and offers a hybrid work arrangement .
This position plays a key role in ensuring Sanofi’s products comply with regulations while influencing and shaping the regulatory landscape in the UK.
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Regulatory Affairs Manager employer: Sanofi
Contact Detail:
Sanofi Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks in the UK, especially those related to OTC products and consumer healthcare. Understanding the nuances of these regulations will help you stand out as a knowledgeable candidate.
✨Tip Number 2
Network with professionals in the regulatory affairs field, particularly those who work with consumer healthcare products. Attend industry events or join relevant online forums to build connections that could lead to valuable insights and opportunities.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory affairs by following key publications and organizations. This knowledge will not only prepare you for interviews but also demonstrate your commitment to the field.
✨Tip Number 4
Highlight any experience you have with managing marketing authorization applications or compliance processes in your discussions. Being able to share specific examples of your past work will showcase your expertise and readiness for the role.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Manager position at Sanofi. Understand the key responsibilities and required qualifications, especially regarding UK regulatory affairs and consumer healthcare regulations.
Tailor Your CV: Customize your CV to highlight relevant experience in regulatory affairs, particularly with OTC products, vitamins, and supplements. Emphasize any previous roles that involved managing marketing authorization applications or compliance with regulations.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the regulatory landscape in the UK. Mention specific experiences that demonstrate your ability to influence regulatory changes and manage compliance effectively.
Highlight Teamwork Skills: Since strong matrix team working skills are essential for this role, provide examples in your application that illustrate your ability to collaborate across departments and drive regulatory excellence within a team setting.
How to prepare for a job interview at Sanofi
✨Show Your Regulatory Knowledge
Make sure to brush up on UK and international regulatory affairs, especially related to Consumer Healthcare. Be prepared to discuss specific regulations that impact OTC products, vitamins, and supplements.
✨Demonstrate Portfolio Management Skills
Highlight your experience in preparing marketing authorization applications and managing product compliance. Share examples of how you've ensured that product labels and promotional materials meet regulatory standards.
✨Emphasize Team Collaboration
Since this role requires strong matrix team working skills, be ready to discuss how you've successfully collaborated with cross-functional teams in the past. Provide examples of how you drove regulatory excellence within a team setting.
✨Stay Updated on Regulatory Changes
Show your proactive approach by discussing how you keep track of emerging regulatory changes. Mention any involvement in local trade associations or relationships you've built with health authorities to influence the regulatory landscape.
