Regulatory Lead

Opella.; Ciudad de México; Sur place; MXN 900 000 - 1 300 000; Plein temps

Résumé du poste

Opella seeks a Regulatory Lead for a 7-month maternity cover in CDMX. You will design regulatory strategies, manage lifecycle activities, and ensure compliance with COFEPRIS while collaborating with Brand & Innovation and external stakeholders to secure timely health authorizations.

The role requires 3–5 years in science/ pharma regulatory areas and leadership experience, with a focus on risk-based decision making and cross-functional teamwork to support product life cycle and advertising

Qualifications

• Education: Bachelor’s degree in Chemical-Biological Sciences (with degree awarded) or related fields.
• 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.

Responsabilités

• Design regulatory strategy for products under responsibility and ensure execution with Regulatory Platform/Center of Expertise.
• Review and define strategy for global/local assessments for new products or projects.
• Lifecycle management of products (renewals, modifications, IPP updates, etc.).
• Provide regulatory input in Brand & Innovation events (workshops, trainings, briefs).
• Ensure submissions to COFEPRIS comply with current requirements.
• Review advertising strategies to ensure regulatory compliance and timely authorizations.
• Communicate potential risks of advertising materials when applicable.
• Maintain global systems related to regulatory impacts of products.
• Build collaboration networks with internal/external stakeholders (chambers, health authority).
• Follow HSE policies and participate in road safety campaigns and investigations.

Formation

Bachelor’s degree in Chemical-Biological Sciences

Master’s degree desirable

Description du poste

Regulatory LeadLocation : CDMXDuration: 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 an 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 .