Cliantha Research is recruiting for the position of Regulatory Analyst in Ahmedabad, Gujarat. The role focuses on regulatory reporting, bioanalytical compliance, regulatory inspection responses, audit observations, and compliance monitoring within clinical research and contract research operations.

Candidates with relevant experience in regulatory reporting and bioanalytical compliance can explore this full-time, permanent opportunity.

Job Details

Positions

Cliantha Research has an opening for a Regulatory Analyst to support regulatory and client audit responses, coordinate with Quality Assurance (QA) and Bioanalytical teams, and monitor compliance commitments.

Key Responsibilities

The selected candidate will be responsible for:

• Preparing responses to regulatory inspections and client audit observations within defined timelines.
• Collaborating with QA and Bioanalytical teams to collect, review, and compile data for regulatory and audit responses.
• Tracking compliance commitments and ensuring their effective implementation.
• Supporting in-process and retrospective bioanalytical monitoring activities.
• Hosting client site qualification visits.
• Presenting laboratory capabilities and compliance systems to clients.

Eligibility and Qualifications

The following educational qualifications are listed for the Regulatory Analyst position:

Undergraduate qualifications

• B.Pharm – Any Specialization
• B.Arch – Any Specialization

Postgraduate qualifications

• M.Pharm – Any Specialization
• MS/M.Sc (Science) – Any Specialization

Candidates with 4–7 years of experience relevant to the role can explore this opportunity.

Required Skills

The key skills associated with this position include:

• Regulatory reporting
• Bioanalytical compliance
• Clinical research
• Regulatory operations
• Regulatory compliance
• Regulatory guidelines
• Regulatory audits
• Regulatory submissions
• Regulatory affairs
• Regulatory requirements
• Method development
• Method validation

Application Details

Application Link