Execute the Regulatory Road Map of the products in the assigned portfolio and at a transversal level as required by the area. Ensure compliance with local regulations to achieve the regulatory objectives for the subsidiary. Provide advisory and support to HQ stakeholders, marketing, logistics, quality, planning divisions, among others, in the projects that are required. Interact with the agency, follow up on regulatory filings and procedures related with the portfolio and projects assigned as required. Also, this role is responsible for leading the evaluation and notification of Promotional and Non-Promotional Materials of the company, as required, to the regulatory agency.
Main Functions
- Be updated on new or changes in laws, regulations, normative, in force or under proposal to keep the company aware and in compliance with the different government regulations.
- Ensure and execute regulatory strategy and compliance for preparation, submission and monitoring of the regulatory procedures such as New Registrations (OMA), New indications, Renewals, Variations (PAC),



and other regulatory procedures in general, etc. for the assigned Portfolio and at a transversal level as required.
- Evaluate, review, and timely present to the regulatory agency the materials used from Oncology, Pharma, Vaccines, and Access business units in promotional and non-promotional activities as required. Ensuring compliance with current regulations and providing cross-functional support in the impacted processes.
- Support Tenders and Sales (and other areas that may require it) obtaining the necessary documentation for their processes (eg Letters, GPM, Certifications, among others)
- Establish good working relationships with both internal and external staff (regulatory agency, associations, regulatory consultants) maintaining a professional image on behalf of the company.
- Execute labeling updates (information to prescribe and insert) of the products within the established due dates. Planning

📌 Regulatory Affairs Specialist (Bogotá, D.C.)
🏢 MSD LATAM
📍 Bogotá, D.C.