Regulatory Affairs Officer

Veeda CR; Ahmedabad District; On-site; INR 1,400,000 - 2,000,000; Full time

Job summary

Veeda CR is seeking an experienced Regulatory Affairs professional to oversee evaluation, regulatory compliance, and submissions for BA/BE studies and clinical trials, coordinating with CDSCO/DCGI and other authorities in India.

You will manage documentation, budgeting, liaison with regulators, and review of sponsor documents, ensuring timely approvals and accurate records while monitoring regulatory changes and guiding cross-functional teams.

Responsibilities

• 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.
• 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.
• 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.
• 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 escalates critical issues or delays to management.
• 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.
• Maintain and circulate the regulatory application status tracker weekly to management, Project Managers, and concerned stakeholders.
• Track submissions, queries, approvals, and pending activities, and escalates 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

Job description

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 escalates 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 escalates 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