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

📌 Regulatory Affairs Officer (Ahmedabad)
🏢 Veeda CR
📍 Ahmedabad