Regulatory Affairs Manager

Job Description

Position Overview: We are seeking an experienced Clinical Trial Regulatory and Operations Manager based in Delhi/NCR/ Mumbai/ Bengaluru/ Hyderabad who will ensure the timely initiation and successful execution of clinical trials. The ideal candidate will have extensive knowledge of India's clinical trial regulatory landscape, CDSCO submissions, import licensing, and operational oversight of clinical research activities. This position reports directly to the Managing Partner. Key Responsibilities: Manage end-to-end regulatory submission processes including preparation and submission of Clinical Trial Applications (Form CT-04) and Import License Applications (Form CT-16 & CT-17). Ensure product labeling and documentation fully comply with NDCT Rules (2019) and other CDSCO requirements. Coordinate with CDSCO, Ethics Committees, and clinical sites to achieve timely approvals and clearances. Oversee CRO activities, ensuring alignment with project timelines and regulatory compliance, including handling of tripartite agreements if necessary. Lead operational planning, site initiation visits, and investigator training programs. Monitor import logistics, inventory management, and ensure compliance with investigational product handling guidelines. Conduct regular cross-functional meetings and status reviews, proactively addressing issues and mitigating potential delays. Global Regulatory Submissions: Need to have experience in preparation and submission of comprehensive regulatory dossiers/ GCT for the US FDA, CDSCO (India). Qualifications: Bachelor's degree required; advanced degree preferred in Life Sciences, Pharmacy, or related fields. Minimum 10 plus years of experience in clinical trial regulatory affairs and operations in India. Strong experience with CDSCO submissions, IMPD/CMC dossier preparation, ethics committee coordination, and investigational drug importation. Previous exposure to complex biologics or antibody-drug conjugates is strongly preferred. Excellent project management, problem-solving, and interpersonal skills. Proficient in English and Hindi, with strong written and verbal communication abilities. Show more Show less