Profile HR Consultants Pvt Ltd | Manager Pharma Regulatory Affairs

2 days ago


india Profile HR Consultants Pvt Ltd Full time

CLIENT: Leading Pharma organization servicing regulated markets like US, Europe and developing markets of Africa and Asia.

Key Drivers:

  • Manage day-to-day regulatory operations along with quality assurance, implementation & Regulatory compliance in line with (GRP) Good Regulatory practice and cGMP best practices industry / Pharmaceutical field.
  • Maintaining the Regulatory and QMS documentation as per the perspectives of cGRP and cGMP regulations.
  • Manage & Co-ordination between Company and Drug control departments of State FDA, and CDSCO (DCGI – India), for product registration, license application, and certification.
  • Filing dossier application, Import Registration and Query reply, Publishing, Regulatory Compliance through SUGAM online portal to Health agency.
  • Participate in Regulatory audit (WHO, CDSCO, TFDA, COPP, GMP audit).
  • Review of all regulatory submission related documents for Drug substance and Drug Product – Like CTD Modules, CMC, MFR, BMR, BPR, PVP, PVR, and Stability, Artwork review, standard testing procedure (STP) and Specification.

·

Incumbent profile:

  • Result driven professional with 10 years experience in Quality Assurance, Research & Development (Pharmaceutical),Regulatory Affairs.
  • Extensive experience in Quality Assurance and management of Regulatory Affairs for formulations, and active pharmaceutical ingredients.
  • Comprehensive understanding of the latest requirements of the regulatory bodies - US FDA, ANVISA, MHRA, TGA, EMEA & MCC and compliance with cGMP, ICH GCP & GLP guidelines.
  • Well versed in preparing and reviewing dossiers for regulatory submissions complying with CTD e-CTD formats and CTD module requirements.

ANNUAL COMPENSATION: 20LPA


Queries:

Anoop Sinha, Director,

PROFILE HR CONSULTANTS PVT LTD

India

< >

Cell-(+91) 9773520069



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