Chennai, Tamil Nadu
Job Summary
The Regulatory Domain SME is responsible for providing domain expertise across pharmaceutical, biotechnology, medical device, and healthcare regulatory processes. The role supports regulatory strategy, submission planning, compliance management, and regulatory intelligence initiatives while ensuring adherence to global health authority requirements including FDA, EMA, MHRA, PMDA, ICH, and other regional regulations.
The SME collaborates with business stakeholders, regulatory affairs teams, quality teams, IT teams, and external partners to design, implement, and optimize regulatory processes, digital solutions, and compliance frameworks.
Experience:
8–15+ years of Life Sciences industry experience.
At least 5+ years in Regulatory Affairs or Regulatory Compliance.
Experience supporting global regulatory submissions and compliance initiatives.
Key Responsibilities
Regulatory Strategy & Compliance
Provide expert guidance on global regulatory requirements and submission processes.
Interpret and apply regulations, guidelines, and standards including:
FDA
EMA
ICH
eCTD
GxP (GCP, GMP, GLP)
21 CFR Part 11
EU MDR/IVDR (where applicable)
Support regulatory impact assessments for new products and market expansions.
Ensure compliance with evolving global regulations.
Regulatory Submission Management
Support preparation, review, and submission of regulatory dossiers.
Guide teams on submission planning, document requirements, and approval workflows.
Review regulatory documents for completeness, consistency, and compliance.
Assist in health authority responses and deficiency management.
Regulatory Intelligence
Monitor emerging regulations and industry trends.
Analyze regulatory changes and assess business impact.
Develop regulatory intelligence reports and recommendations.
Maintain knowledge repositories and regulatory best practices.
Quality & Risk Management
Participate in audits, inspections, and compliance assessments.
Identify regulatory risks and recommend mitigation strategies.
Support CAPA and quality improvement initiatives.
Ensure traceability, audit readiness, and documentation compliance.
Digital Transformation & Systems Support
Act as business SME for Regulatory Information Management (RIM) systems.
Support implementation and validation of:
RIM platforms
eCTD solutions
Document Management Systems
Clinical and Regulatory Data Platforms
Define business requirements and review solution design.
Collaborate with IT teams on system enhancements and data governance.
Domain Expertise
Regulatory Affairs
Regulatory Intelligence
Submission Planning
eCTD Publishing
Labeling Management
Clinical Trial Regulations
Pharmacovigilance Awareness
Quality & Compliance Management
Health Authority Interactions
Technical Knowledge
RIM platforms (Veeva Vault RIM, IQVIA RIM, ArisGlobal, etc.)
Veeva RIM exp for submission
CMC Regulatory Knowledge
Electronic Document Management Systems (EDMS)
Regulatory Data Standards
Validation and Computer System Compliance
Audit Trails and Traceability
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