We are seeking an experienced Clinical Trial Regulatory and Operations Manager based in Delhi/NCR who will ensure the timely initiation and successful execution of clinical trials. The ideal candidate will have extensive knowledge of Indias 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. Qualifications: Bachelors 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.

Lead and oversee daily operations for assigned clinical studies, ensuring timely completion within established goals, regulatory guidelines, and project objectives Manage cross-functional study teams (including vendors), collaborating with preclinical development, regulatory affairs, and project management to coordinate clinical study activities Maintain study timelines, proactively addressing and escalating potential delays to project management Conduct and oversee study monitoring visits, providing regular progress updates to stakeholders and resolving study-related issues Implement and maintain quality standards across investigative sites, vendors, and data management, ensuring compliant clinical study files Lead vendor selection and manage vendor relationships, conducting feasibility assessments for country and site selection Oversee clinical data cleaning, analysis, and reporting, participating in data reviews and statistical analysis planning Review and edit data summaries, presentations, training materials, and study documents Develop and implement effective training programs for investigators, site monitors, and internal/external study teams Required Qualifications: BSc Nursing degree with at 15 plus years in the same field Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability