Regulatory Affairs Associate Director

Job DescriptionJoin our TeamOur Regulatory Affairs Team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.The position is responsible and accountable for the planning of regulatory activities and processes, definition of strategies and development of the effective annual program’s execution for the renewal’s registration, legal renewals documentation, variations and approvals of products according to the business plan. Also, responsible for ensuring the policy and regulatory compliance of processes related with the area, besides providing an active participation in the pharmaceutical industry groups and associations.Regulatory scope: Ensures new products approvals of pharmaceutical products and medical devices, as well as renewals and variations during the cycle life of the products, in accordance with the business plan.Ensures the compliance of regulatory plans, foresee any risks, and establish mitigation plans to mitigate/avoid any impact in the commercialization/products availability, new products launches and line extensions. Liaises with local regulatory authority as required, to facilitate the review, responses to questions and approval of all local submissions in a timely manner.

Manages issues with regards to re-registrations/renewals of products, in compliance with timelines set by the respective regulatory authorities and communicated in the re-registration/renewal plan. Manages and update all internally required reporting activity. Provides regulatory support for cross functional activities within the affiliate e.g., Pharmacovigilance, Pricing, Reimbursement Activity (if applicable), and government bids, among others. Responsible for timely updates of regulatory communication systems.

**Compliance scope**: Manages agency interface for safety and compliance issues. Demonstrates knowledge of, and ensure compliance to, all relevant regulatory legislation and internal procedures. Sets quality standards, by participating in the development of appropriate Standard Operating Procedures' and Work Instructions for affiliate activities such as submissions, license maintenance, agency interface, labeling, promotional review, Quality Assurance actions among others, per requirements of the policies and applicable local regulations. Responsible for timely Submission / Approval of variation / Request for change.

Maintains compliance with labeling database, besides all current company databases. Project Management and Communication scopes: Monitors actual versus planned regulatory activities and timelines, while identifying and recommend improvements to accelerate project progression. Establishes and maintain a strategic partnership through effective, timely, communication with Area Commercial, Medical and Regulatory for all products. Represents Regulatory on cross functional initiatives.

Works on continuing improvements and simplification. Responsible for Development and maintenance of a consolidation work plan and tracking system. Full utilization of regulatory communication processes. Management of direct report scopeSets up priorities, organizes, oversees, and monitors direct report's activities, towards divisional and regional key objectives, while ensuring the compliance with policies and standards.

Ensures that direct reports are appropriate trained for duly performance of responsibilities. Provides good team management and coaching, while fosters talent development and high-performance team’s construction. Fosters psychological safety and well-being among the staff. Requirements: Bachelor’s degree in Pharmacist or related sciences and hold a Specialty in Pharmacist or related sciences.Five (5) or more years of experience in Regulatory Affairs at a Pharmaceutical Industry.Experience working in Central America, Caribbean and Venezuela Regulatory regulations, International sanitary regulation expertise, Requirements and Processes for registration of Biologic, Biotechnological and Chemistry synthesis products.Experience in management and development of teams.Proficiency in Spanish and Fluency in English, in oral and written.Willing to travel 20% of the timeWe are a research-driven biopharmaceutical company.

Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.Who we areWe are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, br