Head of Regulatory Affairs

Role:
Head of Regulatory Affairs

Industry: Pharmaceuticals

Employment Type:

Full-time

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.

• 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 life cycles.
• 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.

• 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.

• 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.

• 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.

• 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.