Head of Regulatory Affairs

Pareto People Pty; Abu Dhabi; On-site; AED 400,000 - 700,000; Full time

Job summary

Pareto People Pty is seeking a strategic Head of Regulatory Affairs to lead regulatory compliance for the UAE and broader MENA region. You will drive complex regulatory strategies, secure approvals, and maintain lifecycle compliance across multiple products.

With 10–15 years in Regulatory Affairs and UAE/MENA experience, you will build strong agency relationships, guide cross-functional teams, and oversee inspections and adverse event reporting to uphold product quality and safety.

Qualifications

• Bachelor’s degree in Pharmacy required.
• Minimum 10–15 years of pharmaceutical Regulatory Affairs experience.
• Regional UAE/MENA expertise preferred.
• Strong communication, teamwork, and proactive decision-making.

Responsibilities

• Develop and drive regulatory strategies to secure approvals and variations.
• Lead liaison with MOH and regional agencies; ensure transparent reporting.
• Oversee regulatory inspections, audits, and post-marketing compliance.
• Mentor Regulatory Affairs team and foster a culture of quality.

Skills

Regulatory affairs

Leadership

Strategic planning

Stakeholder management

Quality & compliance

Education

Bachelor's degree in Pharmacy

Job description

Role: Head of Regulatory Affairs

Industry: Pharmaceuticals

Employment Type: Full-time

About the Role

We are seeking a highly strategic and experienced Head of Regulatory Affairs to lead our regulatory compliance landscape across the UAE and broader MENA region. In this pivotal leadership role, you will be responsible for navigating complex regulatory frameworks, ensuring safety and efficacy standards, securing product approvals, and maintaining compliance throughout the entire product lifecycle.

Key Responsibilities

Strategic Business Performance

• Develop and execute robust regulatory strategies to accelerate the approval of new products, line extensions, and variations.
• Partner with cross-functional teams (R&D, Manufacturing, Marketing, Legal) to seamlessly integrate regulatory milestones into product lifecycles.
• Proactively monitor regional regulatory changes, assess business impact, and deliver expert guidance to internal stakeholders.
• Oversee corporate risk assessments, direct risk minimization strategies, and monitor safety data to enhance the safety profile of our products.

Authority Relations & Stakeholder Engagement

• Serve as the primary liaison and trusted point of contact for the Ministry of Health (MOH) and other regional regulatory agencies.
• Build and maintain strong partnerships with industry associations, healthcare professionals, and external stakeholders.
• Ensure transparent adverse event reporting, safety issue resolution, and accurate, high-quality dossier submissions.

Quality & Inspection Leadership

• Maintain strict compliance with current regulatory guidelines across clinical development, manufacturing, and post-marketing operations.
• Lead all regulatory inspections and audits, coordinating swift responses and executing corrective and preventative actions.
• Drive a progressive culture of quality, ethics, and compliance across the broader organization.

People & Talent Development

• Lead, mentor, and empower the Regulatory Affairs team, fostering an environment built on continuous learning, accountability, and collaboration.
• Establish clear expectations and provide dedicated professional growth opportunities for team members.

Candidate Requirements

• Education: Bachelor’s degree in Pharmacy is mandatory.
• Experience: Minimum of 10–15 years of proven experience in pharmaceutical Regulatory Affairs.
• Regional Expertise: Solid track record in Public Affairs and Regulatory Affairs within the UAE. Additional experience navigating the broader MENA region is highly advantageous.
• Core Competencies: High professional intelligence with an exceptional background in effective communication, teamwork, innovation, and proactive decision-making.
• Analytical Power: Strong problem-solving skills to design unique workaround strategies in complex regulatory environments.