Participate in the regulatory activities of full spectrum of formulation development, from clinical trials to marketing to post approval activities.
Ensure the appropriate licensing, marketing and legal compliance of the finished dosages.
Review the documents at each stage of formulations development.
Highlight the regulatory issues that can be there and try to resolve them.
Coordinate with R&D, AR&D, QA, etc. to collect the complete set of documents.
Compile the ANDA document to be submitted to FDA.
Ensure the documents are error free and have minimum deficiencies.
Prepare annual reports and send them to FDA.
Manage change controls and deviation controls.
Keep themselves abreast of international legislation, guidelines and customer practices
Develop and write clear arguments and explanations for new product licenses and license renewals.
Advise PDTs on regulatory requirements.
Respond to the queries of Regulatory authorities and customers on time.
Review the process change proposals and provide guidance on change proposals.