Role & responsibilities

- Planning, review and submission of registration dossiers and DMFs to various regulatory authorities and customers for Drug Products and Pharmaceutical Formulation Intermediates.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
- Preparation of Clinical Overview and Non-Clinical Overview as part of dossier submission.
- Review and submission of query responses to meet regulatory authority and customer requirements within stipulated timelines.
- Review of Product Information (SmPC, PIL & Labeling) as per regulatory requirements for submission.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Participate in the development or implementation of clinical trial protocols.
- Implement Regulatory Affairs policies and procedures to ensure regulatory compliance is maintained and enhanced.
- Provide regulatory guidance to departments and development project teams regarding product design, development, evaluation, and marketing.
- Communicate regulatory information to multiple departments and ensure the information is interpreted correctly.
- Develop regulatory strategies and implementation plans for the preparation and submission of recent products.




- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
- Review materials such as marketing literature and user manuals to ensure regulatory agency requirements are met.
- Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
- Evaluate proposed clinical and manufacturing changes for regulatory filing strategies.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
- Coordinate with all involved departments for receipt of documents within timelines.
- Maintain Drug Product Life Cycle Management.
- Circulate Registered Product Information to QA and other Cross Functional Team (CFT) members after successful completion of registration/Grant of Marketing Authorization.
- Train staff on the latest regulatory policies and procedures.
- Develop and maintain local working practices.
- Review and execute License, Supply, and Distribution Agreements.
- Interact with clients regarding business proposals.
- Follow up with clients for commercialization of drug products after completion of registration/Grant of Marketing Authorization in the respective territory/country.
- Initiate and maintain clients' payment status.

📌 Urgent Requirement of AGM - Regulatory Affairs -Formulation OSD (Visakhapatnam)
🏢 Lee Pharma
📍 Visakhapatnam