Regulatory Affairs Specialist(CDSCO, SUGAM,DGCI-Domestic Only)-Mumbai

ConfidentialMumbai, India

5 days ago

Job description

Position : Sr. Executive / Asst. Manager / Deputy Manager-Regulatory Affairs (Domestic).

Location : Andheri, Mumbai.

Qualification : M. Pharm. (Experienced preferred).

JOB DESCRIPTION – Regulatory Affairs (Domestic)

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 / cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution

and implementation of regulatory affairs and safety processes.

Local Regulatory Function (Licensing) :

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.
Confirm product formula and label acceptability, as well as the receipt of necessary licenses,
prior to the release of product.
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.
Ensure timely renewal of drug and food licenses maintained by head office and also branch
offices based at various states in the country.
Online application for obtaining test license for import purpose.
Maintain archival of all regulatory permissions.
Keep abreast of the updates pertaining to regulatory requirements and accordingly
implement them.
Prepare responses to the legal & technical queries raised by the Regulatory authorities.

Compliance of Packaging Modules :

Formulate and implement statutory requirements pertaining to the artworks of the

products (label, carton, package insert, patient information leaflet, etc.).

Review the artwork of all packaging material.

Prepare package insert as per New Drugs and Clinical Trials Rules 2019.

Pharmacovigilance

Provide high quality medical writing from planning and coordination of literature research.

Draft and review PSURs with focus on medical aspects of the products and safety sections.

Review of Risk Management Plans as per Regulatory requirement.

Good knowledge in assessing the risk-benefit of a product and identify any gaps in the

aggregate documents.

Perform scientific review of aggregate reports / ICSRs produced by PV Associates.

Skills Required

Medical Writing, Pharmacovigilance

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Regulatory • Mumbai, India