Gurgaon

Responsible for Regulatory Affairs activities in India and neighbouring markets, encompassing product registrations, regulatory submissions, approvals, renewals, lifecycle management, regulatory intelligence, and liaison with Health Authorities.

The incumbent will support the implementation of internal standards, provide study-level CDISC guidance, conduct quality reviews of deliverables from CRO partners, and ensure clinical data packages meet inspection-readiness criteria for global health authorities.

Review and approve the results of Engineering, Manufacturing, Quality, Service and/or Supplier evaluations and investigations of complaints.

Support data collection for regulatory and internal reports by compiling and reconciling data from multiple source systems and reporting tools within organization.

Bachelors Degree in Pharmacy, Life Sciences, Biomedical Sciences, Biotechnology, Chemistry, Regulatory Affairs, or a related scientific discipline.

Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. 

Coordinate with cross-functional teams, including Clinical, Quality, and Manufacturing, to gather necessary regulatory documentation.

Develop and execute regulatory strategies, providing leadership and guidance on pharmaceutical regulatory requirements across India and South Asia to support product registrations, market access, launches, lifecycle management, and post-market compliance.

To collaborate with internal and external stakeholders like CMC team, supply, commercial, IPR, legal, CROs, Consultants etc to ensure smooth regulatory submissions process