Assistant Manager - Regulatory Affairs

Job description:

Roles and Responsibilities:

- Ensure timely authoring and submission of dossiers (Module 2-5) for regulated and ROW in the eCTD format including familiarity with publishing activities.

- Assessment of change controls, defining the correct variation code and preparation of the variation packages as per the agreed timelines.

- Co-ordinate with various departments to obtain essential scientific data and documents required for dossier preparation and query responses.

- Involve in review of source documents for in-house: product development report, specification (excipients, API and finished product), manufacturing batch record, analytical method, validation report, validation protocol etc.

- Actively participate in the evaluation of regulatory compliance of document/product/ process/test methods changes.

- Candidates should also have sound knowledge of documentation and must be familiar with regulatory requirements.

- Must be aware of the latest country specific guidelines for ROW market and capable of planning and implementing, guiding, supporting, reviewing and finally approving the dossiers and implementing the other defined activities of the department.

- Drug Master File review.

Desired Candidate Profile:

- Knowledge on Compliance Standards and Regulation as applicable to MHRA, EMEA, ROW, CDSCO & other international markets.

- Well versed with ICH, Country specific guidelines for dossier, CTD & ACTD.

- Identify and interpret relevant regulatory guidelines

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