Deputy Manager / Regulatory Affairs

JD

• To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all CIS Countries and other country as per company requirements.
• Responsible for final review of dossier before submission
• To coordinate with technical team for documents required for dossier.
• Reviewing artwork for products as per relevant regulatory authority requirements.
• To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements;
• Provide responses to regulatory agencies regarding product information or issues. Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Responsible for Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
• Contributing to the organization's strategic plan and annual plans, in areas such as quality and risk management, regarding registration matters.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Ensuring that quality standards are met, and all submissions meet agreed deadlines.
• Preparing and participating in presentations on regulatory affairs matters, and providing advice to technical team / LL location.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Train staff in regulatory policies or procedures / guideline, prepare training module related to regulatory updates.
• Develop and maintain standard operating procedures or local working practices / regulatory general procedure.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Establish regulatory priorities or budgets and allocate resources and workloads
• Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
• Manage activities such as audits, regulatory agency inspections, queries or product recalls.
• Investigate product complaints / queries and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
• Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
• Participate in the development or implementation of clinical trial protocols.
• Contribute to the development or implementation of business unit strategic and operating plans.
• Coordinate internal findings and statements with legal department staff.
• To prepare MRM related to Regulatory Affairs and present to management.

Any other responsibility allotted by management.

THANKS YOU

REGARDS

MILAP RATHOD (7486829377)call me

HR DEPARTMENT

OPES HEALTHCARE PRIVATE LIMITED