Assistant Manager, Regulatory Affairs
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 42d ago
Undisclosed8–10 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Description:
Essential Functions:
Additional Responsibilities: Education:
Responsible for managing regulatory affairs activities and regulatory strategy execution to ensure compliance with global regulatory requirements, industry standards, and ethical practices throughout product development and lifecycle management. The role oversees preparation, review, and submission of regulatory dossiers, technical documentation, and product registration applications required for approvals from regulatory authorities. It contributes to monitoring regulatory developments, policy updates, and industry intelligence, evaluating their impact on regulatory strategies and organizational operations. The position coordinates regulatory communications, responses, and compliance documentation for interactions with health authorities. It also collaborates with cross-functional teams to strengthen regulatory goverce, documentation control, and compliance monitoring, supporting timely approvals and sustainable regulatory alignment across markets.
Essential Functions:
- Lead and review dossier compilation publishing for complex submissions
- Oversee DMF compilation review process and submission strategies
- Direct eCTD electronic submissions across regions
- Manage post-submission management and health authority responses
- Ensure robust document version control goverce
- Monitor regulatory intelligence and assess strategic impact
- Drive regulatory supplement reporting and lifecycle updates
- Coordinate regulatory health authority management engagements
- Ensure inspection readiness for DMF and audit preparedness
- Apply risk identification mitigation in regulatory planning
- Ensure sustained regulatory compliance across product lifecycle
- Lead quality audit readiness initiatives
Additional Responsibilities: Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 8 years or more in 8 - 10 Years
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
DossierStrategy ExecutionCompilationRegulatory AffairsEctdRisk IdentificationProduct RegistrationDossier CompilationCompliance MonitoringRegulatory ComplianceoperationscomplianceProduct DevelopmentQuality Audit
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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