Position: Sr. Executive -Regulatory Affairs.

Location: Andheri, Mumbai.

Salary: Up to 7.7lpa

Interview Mode: In person

Qualification: B. Pharm./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/crossfunctional 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. 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.
• 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. o 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.