Job Title: Regulatory Affairs Manager
Location: Sector 88 Noida, Delhi NCR
Reports To: Head of Quality & Regulatory Affairs
Position Summary:
The Regulatory Affairs Manager is responsible for developing and executing regulatory strategies to ensure compliance with applicable laws, regulations, and industry standards. This role manages regulatory submissions, coordinates interactions with regulatory authorities, monitors regulatory changes, and partners with cross-functional teams to support product development, registration, commercialization, and lifecycle management.
Key Responsibilities:
Regulatory Strategy & Compliance:
- Develop and implement regulatory strategies to support product development, market entry, and lifecycle management.
- Ensure compliance with applicable regional and international regulations, standards, and guidance documents.
- Interpret regulatory requirements and provide strategic recommendations to internal stakeholders.
- Monitor emerging regulatory trends and communicate potential business impacts.
Regulatory Submissions:
- Prepare, review, and submit regulatory applications, registrations, renewals, variations, and amendments.
- Coordinate the compilation of technical documentation and supporting materials.
- Manage submission timelines and ensure accuracy, completeness, and compliance.
- Respond to regulatory authority questions, deficiencies, and requests for additional information.
Cross-Functional Collaboration:
- Partner with Research & Development, Quality Assurance, Manufacturing, Clinical, Marketing, and Legal teams to ensure regulatory requirements are integrated into business processes.
- Provide regulatory guidance during product development and change control activities.
- Support product launches and market expansion initiatives.
Regulatory Intelligence:
- Track changes in regulations, guidance documents, and industry standards.
- Assess the impact of regulatory changes on existing and future products.
- Develop action plans to maintain ongoing compliance.
Agency Interactions:
- Serve as the primary point of contact for regulatory authorities and notified bodies.
- Coordinate inspections, audits, and regulatory meetings.
- Maintain professional relationships with regulatory agencies and external stakeholders.
Documentation & Record Management:
- Maintain accurate regulatory files, submission records, and product registrations.
- Ensure documentation is audit-ready and compliant with company procedures.
- Support internal and external audits as required.
Team Leadership (if applicable):
- Manage and mentor regulatory affairs specialists and associates.
- Establish team goals, performance metrics, and development plans.
- Promote continuous improvement and regulatory excellence within the organization.
Qualifications:
Education:
- Bachelor’s degree in Engineering, and advanced certificates in Regulatory Affairs,
- Master’s degree or professional certification in Regulatory Affairs preferred.
Experience:
- 8-15+ years of experience in Regulatory Affairs within medical devices, consumer healthcare, or a related regulated industry.
- Demonstrated experience preparing and managing regulatory submissions.
- Experience interacting with regulatory authorities and supporting audits/inspections.
Knowledge & Skills:
- Strong understanding of applicable regulatory frameworks and quality systems.
- Excellent project management and organizational skills.
- Strong analytical and problem-solving abilities.
- Effective written and verbal communication skills.
- Ability to manage multiple priorities and deadlines.
- Proficiency in regulatory information management systems and Microsoft Office applications.
Preferred Competencies:
- Strategic thinking and business acumen.
- Attention to detail and accuracy.
- Leadership and stakeholder management skills.
- Ability to work independently and collaboratively across functions.
- Strong negotiation and influencing capabilities.
Key Performance Indicators (KPIs):
- Timely completion of regulatory submissions.
- Regulatory approval success rate.
- Compliance audit and inspection outcomes.
- On-time product registration and renewal activities.
- Effectiveness of regulatory risk mitigation initiatives.
- Cross-functional stakeholder satisfaction.
Benefits:
- Health insurance
- Leave encashment
- Paid time off
- Provident Fund
Work Location: In person
