Regulatory Affairs Specialist

2 days ago

Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 8,00,000 - ₹ 12,00,000 per year

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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