Regulatory Affairs and Safety Manager

The position holder will be responsible for coordinating and ensuring that all regulatory activities related to the assigned portfolio are executed in accordance with current regulations. They will oversee the operational implementation of the regulatory strategy defined by Leadership, ensuring that regulatory requirements are met on time and in line with internal quality standards.

Their responsibilities include the end-to-end management of regulatory dossiers, including their preparation, review, submission, and follow‑up with the corresponding health authorities. They will also be expected to oversee the proper application of internal regulatory processes, ensure documentation consistency, and serve as a technical reference point on regulatory matters for the organization’s cross‑functional teams.

The role directly contributes to regulatory risk mitigation, business continuity, and compliance throughout the entire product lifecycle, ensuring that processes are executed in accordance with established corporate, regulatory, and quality guidelines.

• Develop and ensure regulatory compliance for new products in the SelfCare and Intimate Wellness (IW) categories in Mexico, including the preparation and submission of dossiers, amendments, renewals, and follow‑ups with COFEPRIS.
• Assess the impact of regulatory changes applicable to medicines, medical devices, dietary supplements, and cosmetics, communicating risks, opportunities, and recommendations to support business decision‑making.
• Manage and maintain the Regulatory Quality Management System (QMS), including the preparation, follow‑up, and closure of CAPAs.
• Provide technical and documentation support for COFEPRIS inspections.
• Manage regulatory and quality audits related to SelfCare/IW products, ensuring compliance, evidence preparation, and corrective action plans.
• Administer and control permits applicable to the portfolio:
• Import permits (COFEPRIS, VUCEM).
• Advertising permits (COFEPRIS: Medicines, Medical Devices, Cosmetics, and Dietary Supplements).
• Manage sanitary complaints, ensuring internal investigation, traceability, regulatory responses, and the execution of corrective and preventive actions.
• Support due diligence activities for new products or site transfers, ensuring regulatory feasibility in Mexico.
• Create, evaluate, and approve internal quality and non‑quality changes in accordance with the change control system, ensuring both regulatory and documentation compliance.
• Manage the submission of amendments to registrations, supplements, notifications, and other procedures before COFEPRIS, maintaining compliance throughout the product lifecycle.
• Review and approve artwork and packaging materials for medicines, medical devices, and cosmetics, ensuring alignment with Mexican regulations (labeling, NOM requirements, commercial information, claims, precautionary statements).
• Collaborate with internal teams (Marketing, Supply, Legal, Quality, Vigilance, Regional Regulatory, Global Regulatory, etc.) to define regulatory strategies that enable competitive product launches and ongoing compliance.
• Provide support in post‑marketing surveillance obligations: pharmacovigilance, technovigilance, complaints, adverse event follow‑up, corrective actions, and sanitary complaints.
• Interpret and apply current Mexican health, advertising, and labeling regulations, keeping the business informed about relevant regulatory trends for the SelfCare and IW categories.
• Participate in industry working groups (AFAMELA, CANIFARMA, AMCHAM, among others), contributing to regulatory discussions and anticipating relevant changes.
• Advise cross‑functional teams on all applicable regulatory requirements to ensure the SelfCare and IW portfolio remains compliant throughout its lifecycle.
• Provide direct support to the plant and distribution center in: GxP activities requiring Regulatory support.