KEY RESPONSIBILITIES :
- Manage all aspects of the regulatory process for US and Canada submissions, viz, review and submission of the marketing authorization application, timely and satisfactory response to the deficiency letters
- To prepare and co-ordinate the submission of supplements, drug listing, renewals, etc.
- Manage a team that consists of several regulatory affairs personnel
- Participate in product teams with regard to implementation of regulatory requirements.
- Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.
- Provide regulatory expertise to analytical and formulation development teams and ensure that information is interpreted correctly.
- Review of the technology transfer documents with regards to US and Canada specific requirements.
- Handling of change controls.
- Maintain a working knowledge of regulatory requirements and guidelines and communicating changes in regulatory information to the team members.
- Update licensing and collect information on registration instructions and regulations.
- Maintain database of FDA-approved and marketing approved drugs
- Flexibility to work for other regions, based on internal requirements, if required
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