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