Regulatory Affairs Officer

Dr. Reddy’s is a global pharmaceutical leader committed to providing affordable and innovative medicines. Our Jamaica operations are expanding, and we’re seeking a detail-oriented and proactive Regulatory Affairs Officer to join our team!

Purpose:

Join a purpose-driven team at Dr. Reddy’s Laboratories Jamaica Limited, where your expertise in regulatory affairs helps bring affordable, high-quality medicines to those who need them most. Be part of a global mission—because good health can’t wait!

The Regulatory Affairs Officer is responsible for overseeing and ensuring the accurate and timely registration, approvals and compliance of the Company’s product with drug regulatory authorities across current commercial markets, as well as potential territories. This role involves liaising with regulatory agencies, maintaining adherence to industry regulations and facilitating market entry processes to support the Company’s growth and operational success

Main duties and responsibilities

• Lead the process of registration, approvals, and permits, ensuring seamless market entry for Dr. Reddy’s products.
• Ensure timely registrations in assigned countries and prepare monthly registration reports for each region.
• Develop strategies and action plans for product registrations, renewals, variations and necessary modifications.
• Responsible for ensuring accurate registration, modifications, and compliance of dossiers and formats before local authorities.
• Co-ordinating with CFT’s for samples submission along with dossier , application of relevant import permissions.
• Submission of deficiencies responses within time to enable on time approvals.
• Perform market intelligence analysis to assess competition and trends in various regulatory landscapes.
• Prepare periodic reports as required by the Country Head for review and strategic planning.

• Identify registration timelines and communicate with internal and external stakeholders to optimize market entry strategies.
• Maintain close collaboration with internal stakeholders to gather regulatory insights and strengthen relationships with healthcare professionals, and industry influencers.
• Oversee trademark registration processes in collaboration with external consultants.
• Manages the Licence Application process/procedure in accordance with any, and all policy guidelines as may be prescribed, and in accordance with the laws of Jamaice