Regulatory Lead

Opella; Ciudad de México; Sur place; MXN 700 000 - 1 100 000; Plein temps

Résumé du poste

Opella seeks a Regulatory Lead in CDMX for a 7-month maternity-cover role. You will shape regulatory strategy, ensure compliance, and guide lifecycle management across brands and products.

Collaborate with Brand & Innovation, Commercial, and external authorities to secure timely approvals and maintain high regulatory standards. Ideal candidates have 3–5 years of pharmaceutical regulatory experience, leadership capability, and a degree in Chemical-Biological Sciences (Master’s preferred).

Qualifications

• 3–5 years in science/ pharma regulatory roles with leadership exposure.

Responsabilités

• Design regulatory strategy for products under your responsibility and execute it with cross-functional teams.
• Review global/local assessments for new products or projects.
• Oversee lifecycle management including renewals, modifications and updates.
• Support brand/innovation events with regulatory input and brief development.
• Ensure COFEPRIS submissions meet current requirements.
• Review advertising strategies for regulatory compliance and timely authorizations.
• Identify and communicate potential regulatory risks in materials.
• Maintain regulatory systems and monitor global regulatory impacts.
• Build networks with internal/external stakeholders and uphold ethics.

Connaissances

Regulatory affairs

Quality

Manufacturing

Pharmacovigilance

Leadership

Formation

Bachelor’s degree in Chemical-Biological Sciences

Master’s degree desirable

Description du poste

Regulatory Lead

• Location: CDMX
• Duration: 7-month temporary position (maternity leave coverage)

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As a Regulatory Lead , you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.

About the job:

Responsible to provide strategic support, take decision on base of risk on base of local/international regulation and ensure the success Opella´s projects (e.g. innovations, life cycle management, advertising, switch, etc.) with internal and external stakeholders.

Main responsibilities:

• Design of the regulatory strategy for the products under your responsibility, and ensure its execution through coordinated work with the Strategic Regulatory Platform - Center of Expertise (when applicable), submitting requests for classification consultations, product operation notices, new registrations, modifications to registration conditions, registration renewals, registration cancellations or product withdrawals, or any other process according to their regulatory classification, in a timely and proper manner, in order to obtain the health authorizations required by the business units.
• Review and definition of the strategy in relation to global and/or local assessments for new products or projects.
• Lifecycle management (renewals, modifications, IPP updates, etc.) of the products.
• Regulatory input in events organized by the Brand & Innovation teams such as workshops, Brand Plans, trainings, development of briefs (do’s & don’ts), etc., related to brand strategies.
• Ensure that the information submitted to COFEPRIS complies with current requirements.
• Participate in the review of advertising campaign strategies with the Brand & Innovation and Commercial areas, ensuring compliance with current advertising regulations to obtain authorizations in a timely and proper manner.
• Communicate potential risks of advertising materials (when applicable).
• Analysis, updating, and maintenance of global systems related to possible regulatory impacts of the company’s products.
• Establish and maintain effective collaboration networks with internal and external stakeholders (e.g., chambers and associations, health authority, etc.). Build trust-based relationships and strengthen Sanofi’s image in adherence to the Code of Ethics and current regulations.
• Know and apply HSE policies and procedures on accident prevention, mainly in road safety, and promote the HSE culture.
• Actively participate in accident investigations and apply the Road Safety Observers program.

About you:

• Education: Bachelor’s degree in Chemical-Biological Sciences (with degree awarded) or related fields. Master’s degree desirable.
• Minimum 3-5 years in Science Affairs/pharmaceutical experience (Medical, Regulatory, R&D or similar), including leadership roles.
• Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Development, Clinical Research, or research in health-related areas.

This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella.

About Us:

Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.

Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.

At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.