Regulatory Affairs

3 weeks ago

Hyderabad, Telangana, India CIEL HR Full time

Roles and Responsibilities DMF submissions Annual Reports Variations Renewals etc for US and Europe market Compilation and publishing in eCTD CTD format for Submission to health agencies like EDQM USFDA etc Oversee final technical quality review and technical validation PDF eCTD NeeS Review all regulatory agency submission materials for accuracy comprehensiveness or compliance with regulatory standards Provide deficiencies responses to HA regulatory agencies for deficiencies and comments Evaluation of change controls for post-approval changes PAC Compilation review and submission of Variations Keeping up to date with changes in regulatory legislation and guidelines Conduct Pre-submission and Initial Submissions meetings Preparation of gap analysis report of CMC regulatory submission including recommendations to facilitate the review of application by HA Gaps in manufacturing and controls assessment of regulatory risk and strategy Providing gap analysis against applicable HA requirements and standards and communicate cross functional team to comply the samezCharacterization of the API and Raw materials used to manufacture the API Description of the product and process development Analytical methods and specifications used for testing Release and stability testing data for both the API Preparation of responses to HA comment letters assessment reports Initial assessment of the submission initial post approval submissions E g initial validation comments response to the completeness assessment report response to the Information Requests

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