Regulatory Affairs (Domestic)

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

Location: Andheri, Mumbai.

Qualification: M. Pharm. (Experienced preferred).

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.