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

Additional Responsibilities:

📌 Assistant Manager, Regulatory Affairs (India)
🏢 Amneal
📍 India