Regulatory Affairs Specialist
23 hours ago
The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with
experience in FDA related activities. This profile will ensure timely and robust functional/crossfunctional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution
and implementation of regulatory affairs and safety processes.
Local Regulatory Function (Licensing):
o Prepare registration dossier for procuring certificates/license from local FDA, DCGI and
FSSAI. This would entail thorough familiarity with FDA, Sugam & FSSAI online portal, Drugs
& Cosmetics Act and its various Schedules e.g. Sch Y, M, etc.
o Confirm product formula and label acceptability, as well as the receipt of necessary licenses,
prior to the release of product.
o Co-ordinate with QC and R&D departments for technical documents (manufacturing
documents like batch records, specifications, analytical methods, validation reports, and
stability data) required to be incorporated in the registration dossiers.
o Ensure timely renewal of drug and food licenses maintained by head office and also branch
offices based at various states in the country.
o Online application for obtaining test license for import purpose.
o Maintain archival of all regulatory permissions.
o Keep abreast of the updates pertaining to regulatory requirements and accordingly
implement them.
o Prepare responses to the legal & technical queries raised by the Regulatory authorities.
Compliance of Packaging Modules:
o Formulate and implement statutory requirements pertaining to the artworks of the
products (label, carton, package insert, patient information leaflet, etc.).
o Review the artwork of all packaging material.
o Prepare package insert as per New Drugs and Clinical Trials Rules 2019.
Pharmacovigilance
o Provide high quality medical writing from planning and coordination of literature research.
o Draft and review PSURs with focus on medical aspects of the products and safety sections.
o Review of Risk Management Plans as per Regulatory requirement.
o Good knowledge in assessing the risk-benefit of a product and identify any gaps in the
aggregate documents.
o Perform scientific review of aggregate reports / ICSRs produced by PV Associates
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