Verified Job
Lab Technician / Pharmacist
Urgent Requirement of AGM - Regulatory Affairs -Formulation OSD
Lab Technician / Pharmacist
#739704
Remote / WFH
Lee Pharma
Job Description
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 new 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.
• 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 new 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.
