Manager, Regulatory Clinical Trials

Job Description:

Responsibilities

• Manage and lead preparation, submission, and tracking of CTAs, substantial/non-substantial amendments, notifications, and other required submissions to Indian Health Authorities (CDSCO) as applicable.
• Ensure timely, complete, and compliant responses to HA questions/deficiency letters to prevent avoidable approval delays.
• Drive readiness and coordination for HA meetings/interactions, including SEC briefing preparation, Q&A preparation, and stakeholder alignment.
• Provide regulatory guidance to study teams on India clinical trial requirements, expectations, and risks; translate requirements into actionable submission plans.
• Oversee regulatory compliance monitoring during study conduct, including compliance with regulatory commitments and conditions of approval.
• Closely cordinate with the Global/International Regulatory Clinical Trials team, GDO, India R&D, Medial team and external partners (e.g., CROs) for regulatory afairs stregies on Clinical trials in India.
• Provide regulatory consultation and guidance to cross-functional study teams on Indian clinical trial requirements, expectations, and risks; translate requirements into actionable submission and mitigation plans.
• Monitor, analyze, and communicate regulatory intelligence related to Indian regulations, guidance, and evolving HA/SEC expectations; assess impacts on the pipeline and studies, and recommend actions.
• Support policy advocacy activities by providing technical and regulatory input, supporting position development, and engagement planning (as appropriate) with industry forums/associations and external stakeholders to help shape a favorable clinical trial regulatory environment.

Qualification & Expeirnece

• Bachelor’s degree in Pharmacy, Life Sciences, Medicine, or related field (advanced degree preferred).
• Minimum 5 years of experience in pharmaceutical industry or CRO for managing regulatory affairs for Clinical trial in India.
• Demonstrated experience in clinical trial regulatory affairs in India, including CTA submissions and amendments.