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.
- Keeping product packaging and information up to date in line with current licenses.
- Implementing mandatory SOPs and ensuring regulatory compliance across the organization.
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- 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.
- Contributing to innovation programs and identifying regulatory risks.
- Overseeing the approval of risk management plans and related materials.
- 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.
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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.