Regulatory Compliance Specialist

20 hours ago


Udaipur, Rajasthan, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000
Job Title: Regulatory Compliance Expert

The regulatory compliance expert plays a pivotal role in ensuring that our organization adheres to regulatory standards and industry best practices. With a strong background in compliance, validation, and testing, you will be responsible for reviewing and implementing systems and processes to ensure compliance with GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.

Key Responsibilities:
  • Compliance and Validation: Hands-on experience in compliance and validation roles, including system validation aligned with regulatory standards, review of validation artifacts, and identification of traceability or documentation gaps.
  • System Life Cycle and Methodologies: Well-versed with System Life Cycle and hands-on experience with Validation approach, Agile methodology, AIML concepts.
  • Testing/Validation Experience: Review and preparation of Test Plans, Validation Plans, Risk Assessments, Requirement Traceability Matrix (RTM), Summary Reports, and understanding of the defect lifecycle and validation deliverables.

Tools and Technologies: Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems, and knowledge of Quality Management Systems (QMS).

Quality & Domain Expertise: Experience in Healthcare, CRO, or Life Sciences environments, and good documentation skills (SOPs, templates, work instructions).



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