Regulatory Affairs Officer

Company : Talentxplore

Job Type : Full Time

Panchkula, Haryana

Number of Applicants

000+

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Job Description - Regulatory Affairs Officer

Assist in the preparation and review of regulatory dossiers in CTD/eCTD format
for submission.
Support in the compilation of documentation for New Marketing
Authorizations, Post-Approval Variations, and Renewals.
Coordinate with departments such as QA, QC, Production, R&D, and
Packaging for data collation and timely submission.
Review and verify product labeling, SmPCs (Summary of Product
Characteristics) and artworks as per MHRA requirements.
Track and manage regulatory submission timelines and maintain regulatory
submission records.
Assist in compiling response packages for deficiency letters / queries from
MHRA.
Support audits and inspections by MHRA by providing required regulatory
documentation.
Maintain awareness of changes in regulatory guidelines and communicate
updates internally

Original job Regulatory Affairs Officer posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.

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Regulatory Affairs Officer

Job Description - Regulatory Affairs Officer

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