Regulatory Affairs Officer

Role & responsibilities

Evaluation & Regulatory Compliance

• Evaluate and communicate applicable domestic and international regulatory requirements for BA/BE studies and clinical trials during feasibility assessment and project initiation.
• Conduct literature reviews and regulatory assessments for conventional and non-conventional studies and advise cross-functional teams on applicable requirements and approval pathways.
• Ensure all necessary study-related and facility-related regulatory approvals are obtained before commencement of activities.
• Monitor regulatory updates and assess their impact on ongoing and planned projects.
• Initiate and coordinate online payment of regulatory fees.

Documentation & Regulatory Submissions

• Prepare, review, compile, and submit regulatory applications for BA/BE studies and Phase I, II, and III clinical trials to CDSCO/DCGI and other applicable authorities.
• Prepare and submit import licence applications for investigational medicinal products and ICMR permissions for importing biological samples, wherever applicable.
• Manage CBN applications and compliance requirements for narcotic and psychotropic substances.
• Prepare and submit applicable regulatory notifications and reports, including SUSARs, SAEs, annual progress reports, and CTRI registrations.
• Maintain records of regulatory applications, approvals, amendments, correspondence, and import/export activities involving controlled substances.
• Ensure timely submission of applications, query responses, and other regulatory documents within defined timelines.

Planning & Budgeting

• Plan and allocate regulatory feasibility assessments, submissions, and follow-up activities among team members in consultation with senior management and Project Managers.
• Prepare annual budgets for regulatory compliance and submission activities.
• Monitor regulatory timelines, resource requirements, and project priorities.

Liasoning

• Coordinate and follow up with CDSCO/DCGI, CBN, ICMR, local FDCA, and other applicable regulatory authorities for approvals, clarifications, and query resolution.
• Liaise with regulatory consultants, sponsors, Project Managers, and internal teams to ensure timely approvals.
• Independently manage routine regulatory queries and escalate critical issues or delays to management.

Communication & Review

• Communicate regulatory updates, guidelines, notifications, and amendments to relevant internal stakeholders.
• Review sponsor and cross-functional documentation for completeness, consistency, quality, and regulatory compliance.
• Provide regulatory guidance on submission strategies, documentation requirements, and approval pathways.
• Coordinate with Project Managers and sponsors to obtain required documents and resolve regulatory deficiencies.

MIS

• Maintain and circulate the regulatory application status tracker weekly to management, Project Managers, and concerned stakeholders.
• Track submissions, queries, approvals, and pending activities, and escalate delays as required.
• Prepare monthly regulatory fee reconciliation statements and obtain the necessary approvals before submission to Finance & Accounts.
• Maintain accurate regulatory records and prepare periodic status reports for management