Regulatory Lead

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing "Health in Your Hands".

Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the "Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World".

We strive to act as a force for good by integrating sustainability along our business and employees' mission and operate responsibly from both a social and environmental point of view.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

The Regulatory Lead is responsible for overseeing and leading the Regulatory activities and the local teams/agents within the zone in scope, with main focus on Panama and ECCO, ensuring compliance of the existing CHC portfolio, effective strategy for regulatory science matters, maintenance, provide appropriate input on the development of new products and ensure engagement with external stakeholders.

Main responsibilities:

Leadership:

• Manage the RA function and define priorities with the relevant local stakeholders.

• Ensure advice and input is provided to local business strategies with regards to regulatory feasibility, requirements, and timelines.

• Oversee the management of RA activities in Panama and ECCO (Ecuador & Colombia).

Regulatory Compliance:

• Ensure product packaging and associated information are updated, timely implemented, and maintained in accordance with the current product licenses.

• Ensure that Marketing Authorizations are updated in line with Company Core Safety Information according to corporate requirements.

• Ensure local implementation of GRA mandatory SOPs and training, as applicable.

• Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs and national regulations.

• Ensure maintenance of regulatory databases.

• Actively follow the development and emergence of new regulatory requirements, ensuring that the impacts are timely communicated to the relevant internal stakeholders.

• Monitor and strive for portfolio harmonization.

Health Authority Interactions:

• Support the local partners on their interfaces with local regulatory authorities.

• Support the participation of local partners in trade associations to influence the regulatory environment in accordance with company strategy.

Portfolio Management:

• Lead the internal processes to ensure proper management of the local maintenance activities and ensure compliance of the marketed product portfolio.

• Ensure the development of local strategies and preparation of OTC switches.

• Ensure that best efforts are provided to get timely approvals of dossiers.

• Monitor the management of advertisement and promotional materials related to CHC products.

Drug Development:

• Give Input to GRA for drug development with regards to local needs (labelling, clinical trials).

Risk Management:

• Coordinate the local health authority approval and implementation of risk management plans and DHPCs and educational material as applicable.

Portfolio Optimization:

• Ensure RA input to product portfolio optimization and product pruning at local level and give RA input to global product portfolio optimization strategies.

Qualifications, knowlegde & skills:

• Experience: 5 years of experience in the pharmaceutical industry and/or mass consumption and regulatory projects.

• Soft skills: Excellent interpersonal and communication skills; agile, adaptable to a fast-paced, high-growth, changing environment, honest team player & problem solver.

• Technical skills: Knowledge of local and international regulatory standards, health regulations, project management and OTC medicines (desirable).

• Education: advanced degree in health care/life sciences such as Pharmacist, Chemical Engineer, Biologist or similar).

• Languages: advanced/fluent working English.

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!