Industrial CMC Regulatory Compliance CHC Lead – Sanofi - Paris

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.

That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core.

Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.

This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers.

We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification.

Join us on our mission. Health. In your hands.

The Industrial CMC Regulatory Compliance CHC Lead position at Opella (Sanofi) in Paris is part of their Risk Management and Compliance team within CHC Global Quality. The role is critical in ensuring that the company’s Consumer Healthcare (CHC) products comply with global pharmaceutical regulations throughout their lifecycle. Below is a detailed breakdown of the role:

Key Responsibilities:

Regulatory Compliance:

Ensure the regulatory compliance of CHC products across various markets, in alignment with Opella Healthcare’s strategic directions and global pharmaceutical regulations.
Maintain compliance for international production sites and distribution activities of CHC products.

Risk Management:

Develop and implement proactive and reactive risk management strategies within CHC entities, ensuring a robust quality risk management culture.

Product Lifecycle and Compliance:

Serve as a Quality Partner for CHC product portfolio management and ensure quality interactions with third parties.
Anticipate regulatory changes through continuous regulatory surveillance.

Process Improvement:

Define and implement effective processes related to regulatory compliance for marketed products.
Develop tools, processes, and training to manage regulatory activities such as change control, product renewals, and license maintenance.

Change Control and Documentation:

Oversee the change control process within the CHC unit portfolio.
Ensure proper coordination of regulatory files and the change control topics within the scope of the role.

Team Leadership:

Manage the Industrial CMC & Compliance CHC team, which consists of 3 people.
Lead and animate the CHC RSO (Regulatory and Safety Operations) network across 13 sites, providing training and day-to-day support.

Cross-functional Projects:

Lead or participate in transversal projects concerning the RSO network or other major CHC projects.

About Sanofi’s Consumer Healthcare (CHC) Vision:

Sanofi’s Consumer Healthcare division aims to lead the next health revolution by empowering consumers to take charge of their own health, fostering self-care and wellness across categories like Allergy, Digestive Wellness, Pain, Mental Wellness, Cough, Cold & Flu. The company is committed to creating a trusted, innovative brand portfolio that enhances well-being while also contributing to a healthier planet.

Qualifications:

Experience: At least 10 years of experience in Quality Management and Regulatory Affairs within an international network.
Technical Skills: In-depth knowledge of GXP, CMC regulations, and pharmaceutical standards across various product types, including drugs, nutraceuticals, cosmetics, and medical devices.
Soft Skills: Strong organization, communication, leadership, and networking abilities.
Education: A degree in Pharmacy or a related life sciences field (Master’s, PhD, or equivalent).
Languages: Proficiency in French and English (spoken and written) is essential.

Ideal Candidate:

The ideal candidate will have a deep understanding of global regulatory frameworks and strong leadership capabilities to manage both the compliance processes and teams. A proactive, solution-oriented individual who is capable of managing regulatory risk and maintaining high standards of product safety and quality would excel in this role.

This is an exciting opportunity for an experienced professional in Regulatory Affairs and Quality Management to contribute to the growth of one of the world’s leading pharmaceutical companies while working in a dynamic, global environment.

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, color, 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

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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.

Pursue progress, discover extraordinary

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!

Opella Healthcare International SAS jobs

Industrial CMC Regulatory Compliance CHC lead