Assistant Manager, Regulatory Affairs

Amneal; Gujarat; On-site; INR 1,500,000 - 1,900,000; Full time

Job summary

Amneal in Gujarat, India seeks an experienced Regulatory Affairs Lead to drive global regulatory strategy and ensure compliance across the product lifecycle. You will oversee dossier preparation, DMF management, eCTD submissions, and health authority communications.

Collaborating with cross-functional teams, you will monitor regulatory developments, assess impacts on strategy, and maintain robust documentation governance and inspection readiness.

Responsibilities

• Manage regulatory affairs activities and strategy execution to ensure global compliance.
• Oversee preparation, review, and submission of regulatory dossiers, DMF and product registrations.
• Monitor regulatory developments and policy updates affecting strategies.
• Coordinate regulatory communications with health authorities.
• Collaborate with cross-functional teams to strengthen governance and compliance.
• Lead dossier compilation and publishing for complex submissions.
• Oversee DMF compilation and submission strategies.
• Direct eCTD submissions across regions.
• Manage post-submission health authority responses.
• Ensure document version control and governance.
• Monitor regulatory intelligence and assess strategic impact.
• Drive lifecycle updates and regulatory reporting.
• Coordinate engagements with health authorities.
• Ensure inspection readiness for DMF and audits.
• Apply risk mitigation in regulatory planning.
• Ensure sustained regulatory compliance across product lifecycle.
• Lead quality and audit readiness initiatives.

Job description

ROLE

• Manage 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.
• Oversee preparation, review, and submission of regulatory dossiers, technical documentation, and product registration applications required for approvals from regulatory authorities.
• Monitor regulatory developments, policy updates, and industry intelligence, evaluating their impact on regulatory strategies and organizational operations.
• Coordinate regulatory communications, responses, and compliance documentation for interactions with health authorities.
• Collaborate with cross-functional teams to strengthen regulatory governance, documentation control, and compliance monitoring, supporting timely approvals and sustainable regulatory alignment across markets.
• Lead and review dossier compilation and publishing for complex submissions.
• Oversee DMF compilation and review process and submission strategies.
• Direct eCTD and electronic submissions across regions.
• Manage post-submission management and health authority responses.
• Ensure robust document version control and governance.
• Monitor regulatory intelligence and assess strategic impact.
• Drive regulatory and supplement reporting and lifecycle updates.
• Coordinate regulatory and health authority management engagements.
• Ensure inspection readiness for DMF and audit preparedness.
• Apply risk identification and mitigation in regulatory planning.
• Ensure sustained regulatory compliance across product lifecycle.
• Lead quality and audit readiness initiatives.