Regulatory Compliance Specialist

1 day ago


Mangalore, Karnataka, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 24,00,000
Job Title: Regulatory Compliance Specialist">

Project Role: Regulatory Compliance Specialist

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Experience: 4-7 years

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Job Location: Bengaluru/Pune/Kochi

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Work Mode: Hybrid

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Must Have Skills: Compliance, Validation and Testing, GXP, System life cycle

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Domain Knowledge: Healthcare, CRO, Life Science

">Key Responsibilities:">
  • Hands-on experience in compliance and validation roles.
  • Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
  • System validation aligned with regulatory standards.
  • Review of validation artifacts and identification of traceability or documentation gaps.
">Required Skills and Qualifications:">
  • Well-versed with System Life Cycle.
  • Hands-on experience with Validation approach, Agile methodology, AIML concepts.
  • Review and preparation of Test Plans, Validation Plans, Risk Assessments.
  • Requirement Traceability Matrix (RTM), Summary Reports.
  • Understanding of the defect lifecycle and validation deliverables.
">Tools and Technologies:">
  • Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems.
">Quality & Domain Expertise:">
  • Knowledge of Quality Management Systems (QMS).
  • Experience in Healthcare, CRO, or Life Sciences environments.
">Good to Have Skills:">
  • Experience with SaaS validation, automation, and vendor audits.
  • Participation in internal/regulatory audits.
  • Strong documentation skills (SOPs, templates, work instructions).
  • Familiarity with risk-based validation and data management.
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Educational Qualification: Any Graduate



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