Manager, Regulatory Clinical Trials

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OBJECTIVES/PURPOSE: Manager Clinical Regulatory Affairs (India) is responsible for managing regulatory activities for clinical trials in India and managing/ supporting preparation submission Q&A and maintenance of Clinical Trial Applications (CTAs) amendments and responses to Health Authority (HA) queries at LOC level and supports HA interactions including Subject Expert Committee (SEC) preparation. This position works in close alignment with the Global/International Regulatory Clinical Trials team GDO India R&D Medial team and external partners (e.g. CROs) for Clinical trials in India.

KEY JOBS ACCOUNTABILITIES:

• 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.
• Define and lead India-specific regulatory strategies for CTAs including pathway optimization risk mitigation and alignment with global regulatory strategy.
• Monitor and report key performance indicators (e.g. submission timelines approval timelines deficiency rates) and drive continuous improvement.
• Utilize regulatory systems (e.g. Veeva RIM) to ensure accurate tracking documentation and compliance across all submissions and interactions.
• Identify regulatory risks proactively and escalate critical issues with mitigation strategies to ensure continuity of clinical programs.

• Ensure regulatory inspection readiness for CDSCO and other regulatory authorities including maintaining compliant documentation and supporting inspections/audits.

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelors degree in Pharmacy Life Sciences Medicine or related field (advanced degree preferred).
• Minimum 7 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.
• Strong working knowledge of Indian clinical trial regulations and HA/SEC expectations and processes.
• Experience coordinating cross-functional inputs to deliver high-quality submission packages under tight timelines.
• Ability to manage vendors/CROs and drive quality compliance and on-time delivery.
• Strong written and verbal communication skills; able to lead HA query responses and internal alignment.
• Strong planning prioritization and global stakeholder management skills in a matrix environment.
• Strong documentation discipline and expertise in RA System and Tool like Veeva