Head Regulatory Affairs

About the client:
PSS
has been mandated to hire a
Head of Regulatory Affairs
for a leading R&D backed, manufacturing women's health organization with operations in over 140 countries worldwide. It is the world's largest manufacturer of Contraceptives devices.

Job Purpose
The Head of Regulatory Affairs will lead global regulatory strategies for medical devices and contraceptive solutions. The role will ensure compliance with domestic and international regulations (and support product approvals, quality assurance, and market expansion.

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.