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UpMan Placements Private Limited
Assistant Manager Safety Variations
UpMan Placements Private Limited · posted 4 months ago
AhmedabadRA,
About the role
ROLE:
· Review and compile product information (SPC, PIL, label) for
safety and non-safety variations.
· Ensure approved PI documents remain aligned with reference
products and regulatory requirements.
· Prepare and review post-approval submissions (RMP, PSUR).
· Draft and review responses to safety variation queries.
· Prepare and publish eCTD dossiers for variations and affiliate
requests.
· Coordinate with affiliates, translators, and other relevant teams
for the timely submission of national texts and mock-ups.