Head Regulatory Affairs (PSS07387)

About the client:

PSS

Head of Regulatory Affairs

Job Purpose

Key Responsibilities

Regulatory Strategy & Compliance:

• Develop and implement regulatory strategies for medical devices and contraceptive products.
• Ensure compliance with CDSCO (India), US FDA, EU MDR, WHO, UNFPA, TGA, ANVISA, and other regulatory bodies.
• Keep abreast of changing regulations and update internal teams accordingly.
• Handle regulatory audits and inspections from government agencies and international bodies.
  

Product Registration & Approvals

• Lead the preparation and submission of dossiers for global product registrations.
• Work with R&D and Quality Assurance teams to ensure compliance with regulatory requirements.
  

Liaison & Stakeholder Management

• Act as the primary point of contact with regulatory authorities, notified bodies, and industry associations.
• Collaborate with government agencies, NGOs and international partners for regulatory approvals and compliance.
• Support business development teams in regulatory due diligence for new markets.
  

Team Leadership & Process Optimization

• Lead and mentor a team of Regulatory Affairs professionals to ensure efficient regulatory operations.
• Develop and implement regulatory SOPs, risk assessments, and compliance training programs.
• Optimize regulatory submission processes to improve approval timelines.
  

Educational Qualifications And Experience

• Education: Master’s degree in Pharmaceutical Sciences, Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
• Experience: 12+ years in Regulatory Affairs within the Medical Device or Pharmaceutical industry.
• Knowledge of relevant regulations.
• Experience in regulatory submissions for contraceptives and medical devices is a plus.
• Excellent leadership, project management, and communication skills.