Veeda CR Hiring for Regulatory Affairs Officer

Veeda CR is hiring for the position of Regulatory Affairs Officer in Ahmedabad, Gujarat. The role focuses on regulatory compliance, clinical trial and bioavailability/bioequivalence (BA/BE) study submissions, regulatory documentation, and coordination with authorities such as CDSCO, DCGI, CBN, and ICMR.

Candidates with a B.Pharma or M.Pharma qualification and 3–5 years of experience can explore this opportunity in the pharmaceutical and life sciences sector.

Job Details

Position

Regulatory Affairs Officer

The selected candidate will manage regulatory assessments, prepare and submit applications for clinical trials and BA/BE studies, coordinate with regulatory authorities, monitor compliance, and maintain regulatory records and submission trackers.

Roles and Responsibilities

1. Regulatory Evaluation and Compliance

• Evaluate domestic and international regulatory requirements for BA/BE studies and clinical trials.
• Conduct literature reviews and regulatory assessments for conventional and non-conventional studies.
• Ensure required study-related and facility-related approvals are obtained before activities begin.
• Monitor regulatory updates and assess their impact on projects.
• Initiate and coordinate regulatory fee payments.

2. Documentation and Regulatory Submissions

• Prepare, review, compile, and submit applications for BA/BE studies and Phase I, II, and III clinical trials.
• Submit applications to CDSCO/DCGI and other applicable authorities.
• Prepare import licence applications for investigational medicinal products and ICMR permissions for importing biological samples, where applicable.
• Manage CBN applications and compliance requirements for narcotic and psychotropic substances.
• Prepare and submit SUSARs, SAEs, annual progress reports, and CTRI registrations, as applicable.
• Maintain records of applications, approvals, amendments, correspondence, and controlled-substance import/export activities.
• Ensure timely submissions and responses to regulatory queries.

3. Planning and Budgeting

• Allocate regulatory assessments, submissions, and follow-up activities 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.

4. Regulatory Liaison and Communication

• Coordinate with CDSCO/DCGI, CBN, ICMR, local FDCA, and other applicable authorities.
• Liaise with regulatory consultants, sponsors, Project Managers, and internal teams.
• Handle routine regulatory queries and escalate critical issues or delays.
• Communicate regulatory updates, guidelines, notifications, and amendments to internal stakeholders.
• Review sponsor and cross-functional documents for completeness, consistency, quality, and compliance.
• Provide guidance on submission strategies, documentation requirements, and approval pathways.

5. Reporting and MIS

• Maintain and circulate weekly regulatory application status trackers.
• Track submissions, queries, approvals, and pending activities.
• Prepare monthly regulatory fee reconciliation statements and obtain required approvals.
• Maintain accurate regulatory records and prepare periodic management reports.

Eligibility and Qualifications

Candidates should meet the following requirements:

• B.Pharma in any specialization, or
• M.Pharma in any specialization.
• 3–5 years of experience in regulatory affairs.

Required Skills

• Regulatory affairs and drug regulatory compliance
• Clinical trial regulatory submissions
• Bioavailability and bioequivalence (BA/BE) studies
• CTD and dossier preparation
• CDSCO/DCGI liaison
• Regulatory documentation and submission tracking
• Regulatory query management
• Regulatory compliance reporting