Sr. Executive/Asst. Manager/Dty. Manager-Regulatory Affairs (Domestic)

From 3 to 8 year(s) of experience
₹ 4,00,000 - 9,00,000 P.A.

Job Description

We have been retained by one of the Top 10 pharma companies to hire Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic Market) to be based at their HO located in the western suburbs of Mumbai. The details of the position are as follows:


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.

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.

Those of you who are interested in this position and will like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com


Role:Healthcare & Life Sciences - Other

Salary: 4,00,000 - 9,00,000 P.A.

Industry:Pharmaceutical & Life Sciences

Functional Area:Healthcare & Life Sciences

Role Category:Healthcare & Life Sciences - Other

Employment Type:Full Time, Permanent

Key Skills
Skills highlighted with ‘‘ are preferred keyskills

Education

UG:B.Pharma in Any Specialization

PG:M.Pharma in Any Specialization

Company Profile

Pharma Placements Inc.

Hiring for one of the Top 10 Pharma Companies.

Company Info
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Contact Company:Pharma Placements Inc.