Assistant Manager/Executive | Regulatory Affairs | Eris Oaknet | Mumbai

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Job Overview

  • Date Posted
    05/09/2022
  • Location (State / UT)
  • Expiration date
    --
  • Experience
    3 Years, 8 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree
  • Salary in (₹)
    Negotiable

Job Description

Key Deliverables of the Job:

Product lifecycle management: (Domestic and Exports)
  • Responsible for licensing & registration of pharmaceutical products with DCGI and SLA (state licensing Authority).
  • Responsible for the online system of submitting applications to State FDA through the respective websites.
  • Renewal of licenses and preparation of applications for renewal of manufacturing license, renewal of WHO-GMP Certificate, validity & extension of WHO-GMP Certificate, product permissions, Certificate of Pharmaceutical Product (COPP), and Free Sale Certificates (FSC).
  • Dossier preparation in CTD and manual formats for submission in ASEAN countries and obtaining the registrations.
  • Responding to post submission queries received on the dossiers submitted to clients and agencies within timelines.
  • Responsible for reviewing the artworks and giving inputs as per the regulatory guidelines (D&C Act)
  • Suggestions about artwork design to the marketing team as per the D&C Act.
New Product Launch (Domestic and Exports)
  • Responsible for Regulatory Filing Strategy inputs with gap analysis once the new product has been identified.
  • Preparing a response to queries of various agencies.
  • Study and suggest designs/artworks of market support.
  • Responsible for New product filings through CTD, ACTD, and regional formats to Health agencies.
  • One-time product approval and Day-1 launch preparation support.
Information Management, NPPA support, and Plant Audit
  • Maintain all regulatory documentation and submissions for domestic and international health authorities
  • Maintain updated information records to keep a track of renewals & license information.
  • Monitoring closely and keeping a track of all the Pharmaceutical products as per NPPA requirements.
  • Responsible for Auditing of Manufacturing Plant with respect to quality and regulatory requirements.

Desired Knowledge & Skills:

  • Experience in managing licensing and registration of pharmaceutical products as per the DCGI and state FDA
  • Knowledge of New product filing and launches, post-approval filings & renewals of various products for various markets as per the country-specific guidelines.
  • Ability to inspect, review, and experience in compliance activities during plant audits as per the guidelines
  • Keeping oneself abreast of changes to the D&C guidelines.
Desired Skills:
  • Excellent communication skills (both verbal and written).
  • Should be a team player with the ability to manage people across departments.
  • Excellent time management skills.
  • Adept in the understanding of systems and processes.