Regulatory Affairs Executive-API Pharma

2 weeks ago

Mumbai Navi Mumbai Panvel, India SANVIN group Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

1.Ensure proper documentation and fulfillment of statutory requirements with regards to various

FDA authorities.

  1. Collect information from various departments and prepare DMFs, Dossiers, amendments

and supplements etc

  1. Submit them to the pertinent regulatory authorities within a specified time frame to get

approval.

  1. Respond to queries as they arise and ensue that regishation/approvals are $anted without

delay.

  1. Coordinate customer and reeulatorv audits.

  2. Provide compliance to customer complaints by coordination with marketing department.

  3. Keep up to date of national and intemational legislations, guidelines (available on websites)

and customer practices and concemed departments about the same.

  1. Keep up to date with a company's product range.

  2. Ensure that a company's products comply with the current regulations.

  3. Formulate strategy for all regulatory submissions.

  4. Participate in regulatory and customer inspections, review audit reports and submit

compliance report to regulatory agency.

  1. Maintain approved applications in compliance with appropriate guidance

  2. Identifling the tlpe of changes & submit them as per country guidelines (life cycle

management).

  1. Monitor progress of all registration submissions country-wise and product-wise.

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