Sr Executive -Regulatory Affairs
Sr Executive -Regulatory Affairs
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Job Description
Job Title: Sr. Executive Regulatory Affairs.
Job Location: Maharashtra
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: Associate
Regulatory Compliance FDA Regulations Quality Assurance Documentation Management Risk Assessment Communication Skills Project Management Regulatory Operations
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 Coordinate 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.
- 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.
- 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 riskbenefit of a product and identify any gaps in the aggregate documents.
- Perform scientific review of aggregate reports / ICSRs produced by PV Associates.
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Employment Type
Full Time
