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:Job details are sourced from the employer's original posting.
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Amneal India is a pharmaceutical company focused on developing, manufacturing, and marketing high-quality generic and specialty pharmaceutical products.