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Executive / Senior Executive - Regulatory Affairs (Domestic)
4 weeks ago
- 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. 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.
- Educational Qualification: B. Pharma / M. Pharma / Pharm D.
- Experience: 1 - 4 years of similar role in a leading Pharma Company.
Those of you whose profile matches the above mentioned description and would like to apply for this job shall forward their updated resume to
