Profile HR Consultants Pvt Ltd | Manager Pharma Regulatory Affairs
2 days ago
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.
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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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