Regulatory Affairs (Injectables or Biologics) | Biological E | Hyderabad

HR / Admin / Office, PharmacoVigilance / Regulatory Affairs
Telangana
April 6, 2023
Full Time
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Job Overview

  • Date Posted
    April 6, 2023
  • Location (State / UT)
    Telangana
  • Expiration date
    --
  • Experience
    15 Years, 20 Years
  • Gender
    Any
  • Desired Qualification
    Master’s Degree

Job Description

Regulatory Affairs – Injectables & Biologics

Roles & Responsibilities:

A. Regulatory activities ROW Countries, WHO, and NRA (CDSCO).

RCGM & GEAC clearance for recombinant products.

  • Biological Products registrations / Marketing Authorization approvals from various regulatory authorities (ROW, WHO & NRA-India).
  • Regulatory strategies development for New Drug approvals/ registrations & Post approval changes (PACs).
  • Regulatory compliance for Biological products (whole cell & subunit vaccines, recombinant vaccines, conjugate vaccines, and viral vaccines (inactivated & live attenuated)).
  • Product life cycle management.
  • Guidance to cross-functional teams on regulatory expectations for India, WHO, and other ROW countries.
  • Active role in providing suggestions/recommendations on various regulatory guidance/ draft regulations (NRA & WHO) to encourage manufacturer responsive regulatory environment without compromising regulatory compliance.
  • Approvals from RCGM/ GEAC for recombinant Products.Preparation, review, and coordination for the creation of CTD modules for Clinical Trial Applications (CTA), Marketing Authorization Applications (MAA), PQ dossiers, and Variations.

Desired Knowledge & Skills

  • Desired Qualification: M.Sc/ M. Pharmacy
  • Desired Experience: 15 to 20 years
  • Location: Genome Valley, Shameerpet, Hyderabad

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