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Executive/Sr.Executive - Regulatory Affairs (Canada Market)

Executive/Sr.Executive - Regulatory Affairs (Canada Market)

Strides Pharma Science

1 - 5 years

4 - 8 Lacs

bengaluru

Posted:Just now| Platform:

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Skills Required

regulatory affairs canada market

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for compilation and assist team for projects and regulatory submissions by collating documents per regulatory requirements for Canada market for CMC and labelling aspects.
Interpret and prepare response to the quality & administrative deficiencies as per regulatory requirement within defined timelines.
Develop and implement regulatory CMC strategies to support post-approval changes (PACs), variations, and life cycle activities
Co-ordinate with cross functional teams for document request, review, required for regulatory submission
Upload and publish the documents in eCTD software required for regulatory submission
Arranging and coordinating trainings within departments

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