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