Senior Quality Assurance and Regulatory Affairs Leader

2 days ago

Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

This role is responsible for the overall direction and oversight of Quality Assurance and Regulatory Affairs functions.

Key Responsibilities
  • Develop and implement QA and RA strategies aligned with business objectives
  • Lead cross-functional teams to ensure quality and regulatory compliance throughout the product lifecycle
  • Represent the company in regulatory and quality discussions with external stakeholders, including regulatory bodies, partners, and auditors
  • Provide regular updates and reports to senior leadership on compliance status, risks, and strategic initiatives
Quality Management System Oversight
  • Ensure compliance with ISO 13485, GMP, GDP, GVP, and MDD/MDR standards
  • Lead internal and external audits, inspections, and quality improvement initiatives
  • Manage CAPA, non-conformance, and complaint handling processes
  • Ensure validation of equipment, processes, and software used in manufacturing and testing
  • Supervise final batch release, documentation control, and production line clearance
Regulatory Affairs Strategy
  • Develop and execute regulatory strategies for global markets
  • Ensure timely regulatory submissions, product registrations, and lifecycle management
  • Maintain compliance with regulatory requirements and marketing practices
  • Lead regulatory due diligence for licensing, acquisitions, and partnerships
Personnel & Team Management
  • Lead and mentor QA and RA teams, defining roles, responsibilities, and KPIs
  • Conduct performance appraisals, training plans, and succession planning
  • Promote a positive working environment and team collaboration
Operational Excellence
  • Oversee supplier qualification, audits, and performance monitoring
  • Ensure compliance with customer-specific quality requirements and contract reviews
  • Manage change control systems and ensure proper documentation and traceability
Qualifications & Experience
  • Master's degree in Pharmacy, Chemistry, Biotechnology, Biomedical Engineering, or related field
  • Minimum 15 years of experience in QA and RA, with at least 5 years in a leadership role in the medical device or pharmaceutical industry
  • Proven expertise in regulatory affairs and quality management systems

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