Assistant Manager, Regulatory Affairs
Assistant Manager, Regulatory Affairs
Amneal Pharmaceuticals- Posted 3 hours ago
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Job Description
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
More Info
Key Skills
regulatory strategy execution
product registration applications
document version control
audit preparedness
eCTD electronic submissions
post-submission management
About Company
Skills:
Regulatory Affairs for Complex Products, Regulatory Strategy Deficiency Response Management, Regulatory Compliance Regulatory Intelligence, FDA Correspondence Meeting Packages, Cross-Functional Collaboration, Post-Approval Filing Management PAS CBE-30 CBE-0, Sterile Nasal Transdermal Topical Dosage Forms, ANDA NDA IND Submission Experience, Technical Writing Documentation