Deputy Manager – Regulatory Affairs | Biological E | Hyderabad

HR / Admin / Office, PharmacoVigilance / Regulatory Affairs
Telangana
February 24, 2023
Full Time
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Job Overview

  • Date Posted
    February 24, 2023
  • Location (State / UT)
    Telangana
  • Expiration date
    --
  • Experience
    8 Years, 10 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Deputy Manager – Regulatory Affairs – Injectable

Roles & Responsibilities:

  • Hands-on experience for sterile complex injectable dossier compilation (regulated markets like US/Canada/EU); Along with regulatory markets, ROW market exposure would be more useful.
  • Drug device combination product work experience
  • Hands-on experience in query response handling & post-approval submissions
  • USFDA-related administrative activities like FEI, Establishment registration, and Self-Identification. DUNS-related activities (Verification and Renewal), Drug Listing;
  • Dossier compilation using the eCTD tool
  • Labeling & SPL knowledge

Desired Knowledge & Skills

  • Good communication and drafting skills
  • Good managerial skills

Qualification & Experience: M Pharmacy with 8 -10 Yrs experience.

Work Location: Shameerpet Hyderabad

Department: Regulatory Affairs

Designation: Deputy Manager

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