Gurgaon

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

The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.The role is critical to meet planned Site Ready dates

Xogene combines regulatory expertise with advanced technology to automate complex processes in clinical trial disclosure. As trusted experts with comprehensive knowledge of global regulatory frameworks, we deliver efficient data transformation and regulatory compliance for our clients, streamlining workflows through our AI and agentic networking capabilities. We're committed to leveraging technological solutions to advance clinical trial transparency.