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Regulatory Affairs

2 weeks ago

Mumbai, Maharashtra, India CliniLaunch Research Institute Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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.