Regulatory Affairs Specialist
hace 6 días
Join us and be part of our purposeful journey of invention
Our 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.
**Responsibilities include but are not limited to**:
Support both local and International strategic initiatives to improve local productivity and reduce cycle times primarily for the Registrations, renewals and Post Approval Changes processes.
Promote compliance with our companies policies, local and international regulations regarding Drug products Marketing Authorizations and Good Manufacturing Practices.
Provide continued support and feedback to local Marketing, Global Regulatory Affairs Clinical Safety regarding status and/or issues.
Plan and perform a regulatory process including preparation of documents for New Registrations, Renewals and Post Approval Changes submission, follow up before the Agency and notification of approval letters.
Ensure that On Line Regulatory information database is updated with the submission/approval dates for all the records for country responsibility and aligned with the pharmaceutical information for each product.
Coordinate and assure a timely review and approval of the Artworks for packaging materials for all products.
Support to Sales Department with Regulatory Documents (Good Manufacturing Practices certificates, Bioequivalence letters and others) for Tender Bids.
Support the other regulatory processes as required by the Manager.
As required, support to the Regulatory Affairs Team.
This position is based in Panamá, and it does not include relocation assistance.
**Requirements**:
Bachelor's Degree ("Licenciatura") in Pharmacy or related sciences.
Three (3) years or more of experience in Regulatory Affairs at Pharmaceutical Industry.
Good knowledge of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Manufacturing Practices and local regulations related to health registrations.
Knowledge of Central America, Dominican Republic & Caribbean regulations.
Proficient in MS Office software
Effective communication skills in English and Spanish both written and oral.
We 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 are
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
Search Firm Representatives Please Read Carefully
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**: R188605
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