Deputy Manager

2 weeks ago

Ahmedabad, Gujarat, India Opes Healthcare Full time ₹ 15,00,000 - ₹ 25,00,000 per year

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 call me

HR DEPARTMENT

OPES HEALTHCARE PRIVATE LIMITED

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