Officer/Sr. Officer/ Executive-Regulatory Affairs (EU-US Market)
Updated: March 15, 2024 10:31 PM GMT
Immacule
Nalagarh, Himachal Pradesh• Coordinate and manage the preparation, compilation, and submission of regulatory dossiers, applications, variations, and other documentation for product registration in ROW markets, ensuring compliance with regulatory requirements, guidelines, and timelines.
• Conduct regulatory intelligence and monitor changes in regulations, guidelines, and requirements in ROW markets, providing insights and recommendations to support regulatory strategies and decision-making.
• Liaise with regulatory authorities, external consultants, distributors, and business partners in ROW markets to facilitate regulatory submissions, address queries, and obtain regulatory approvals and licenses.
• Review and analyse regulatory documents, data, and submissions for accuracy, completeness, and compliance with regulatory standards and company policies, ensuring high-quality submissions and successful outcomes.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, Marketing... More Detail
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