Assistant Manager, Regulatory Affairs
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 52d ago
Not disclosed8–10 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Description
JOB DESCRIPTION
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 governance, documentation control, and compliance monitoring, supporting timely approvals and sustainable regulatory alignment across markets.
Essential Functions
QUALIFICATIONS
Education
JOB DESCRIPTION
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 governance, 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 & governance
- 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
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 8 years or more in 8 - 10 Years
Sourced from foundit
Skills
Regulatory communicationseCTD electronic submissionspost-submission managementproduct registration applicationsregulatory strategy executionTechnical DocumentationAudit preparednessDocument version control
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
Employees rate it well for
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