14 ago
|
Reckitt
|
Ciudad de México
14 ago
Reckitt
Ciudad de México
Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a integral team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.
**Research & Development**:
- In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D;, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
**About the role**:
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.
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.
**Your responsibilities**:
- 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.
- 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.
**The experience we're looking for**:
- Bachelor’s degree in Pharmaceutical Chemistry and Biology, Pharmaceutical Engineering, Industrial Pharmaceutical Chemistry, or a related field.
- Master’s degree in Business Administratio
📌 Regulatory Affairs and Safety Manager (Ciudad de México)
🏢 Reckitt
📍 Ciudad de México