Job Brief:
We are seeking an experienced Regulatory Subject Matter Expert (SME) to provide deep domain expertise, advisory support, and compliance guidance across our regulatory initiatives. The ideal candidate will possess extensive knowledge of industry-specific regulations, compliance frameworks, and best practices. This role requires strong analytical capabilities, the ability to interpret complex regulatory guidelines, and the skill to translate those guidelines into actionable business processes, documentation, and operational controls.
The Regulatory SME will work closely with cross-functional teams—Operations, Legal, Quality, Risk, and Technology—to ensure all business activities, products, and systems comply with applicable laws and standards. The candidate will also support audits, regulatory submissions, risk assessments, policy development, and internal stakeholder training.
Job Requirements: Regulatory SME
1. Education & Experience
- Bachelor’s or Master’s degree in Law, Compliance, Business Administration, Finance, or related field.
- 5–10+ years of experience in regulatory compliance, governance, risk, auditing, or a similar domain.
- Prior expertise working directly with regulatory bodies or regulatory submissions (industry-specific: BFSI, Pharma, Healthcare, IT/ITES, depending on your requirement).
2. Technical & Regulatory Knowledge
- Strong understanding of applicable regulatory frameworks such as:
- For Finance/BFSI: RBI guidelines, SEBI, FEMA, AML/KYC, PCI-DSS, ISO 27001.
- For IT/Technology: Data privacy laws, GDPR, ISO standards, SOC 2, cybersecurity policies.
- For Healthcare/Pharma: FDA, CDSCO, GMP, GxP, HIPAA.
- Ability to interpret complex regulatory documents and convert them into clear business requirements.
3. Key Responsibilities
- Conduct in-depth research and analysis of relevant regulatory guidelines.
- Advise internal teams on compliance requirements and risk mitigations.
- Create, update, and review policies, SOPs, regulatory documentation, and compliance frameworks.
- Support internal/external audits and ensure timely closure of non-compliances.
- Prepare regulatory reports, submissions, and process documentation.
- Monitor regulatory changes and evaluate their impact on business operations.
- Train and guide stakeholders on compliance requirements and process implementations.
4. Skills & Competencies
- Strong analytical, problem-solving, and risk-assessment skills.
- Excellent documentation and presentation capabilities.
- Ability to collaborate with technical and non-technical teams.
- Strong communication skills with the ability to influence decision-making.
- Attention to detail and a structured approach to compliance management.
5. Additional Preferred Skills
- Experience leading regulatory projects or audits.
- Knowledge of process mapping, internal controls, and governance frameworks.
- Certifications such as CISA, CIPP, CAMS, ISO Lead Auditor, or equivalent (preferred but not mandatory).