Executive, Regulatory Affairs
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 38d ago
Undisclosed3–9 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Key Responsibilities
1. Dossier Preparation & Submissions
- Prepare, review, and submit CTD / ACTD / country-specific dossiers for:
- New product registrations
- Line extensions (strength, pack size, shelf life)
- Variations and renewals
- Coordinate compilation of Modules 1-5 with QA, QC, R&D, CMC, PV, PM, and Manufacturing teams.
- Ensure dossier compliance with WHO, ICH, and local authority guidelines .
2. Regulatory Strategy & Market Support
- Support business development by providing regulatory feasibility and timelines for new markets/products.
- Assess regulatory impact for formulation/site changes.
3. Regulatory Lifecycle Management
- Manage post-approval changes , including:
- CMC variations
- Labeling updates
- Artwork changes
- Track and ensure timely renewals/re-registrations .
- Maintain approved product documentation and regulatory databases.
4. Health Authority Interaction
- Handle deficiency letters / queries from regulatory agencies.
- Prepare responses in coordination with internal stakeholders.
- Liaise with local agents, consultants, and partners for RoW countries whenever required.
5. Compliance & Intelligence
- Monitor regulatory guideline updates for RoW markets.
- Ensure submissions comply with the latest country requirements .
Markets Typically Covered (RoW)
- LATAM : Brazil, Mexico, Colombia, Peru, Chile, Guatemala
- MENA/GCC region
- CIS : Russia, Ukraine, Kazakhstan, etc.
- ASEAN : Philippines, Vietnam, Thailand, Malaysia, etc.
Required Qualifications & Experience
- Educational Background:
o M.Pharm / B.Pharm
- Experience:
o 3-9 years in Pharmaceutical Regulatory Affairs
- Educational Background:
o M.Pharm / B.Pharm
- Experience:
o 3-9 years in Pharmaceutical Regulatory Affairs
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Regulatory AffairsCMCMonitoringICHQa/QcExecutive Regulatory AffairsmanagementcompliancePharmaFormulation
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
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