Associate Director, Regulatory Affairs – EEMEA GAIA Project

• Manage complex global regulatory change projects as Regional Regulatory Affairs Project Manager
• Work with 30–40 countries within EEMEA to facilitate on-time regulatory approvals and protect supply to patients
• Liaise between the global sourcing management team and in-country regulatory leads
• Collaborate with regional counterparts across global regulatory and CMC teams to improve processes
• Drive change using a solution-oriented approach
• Plan and track on-time initial submissions and RTQs
• Escalate plan shifts and bundling opportunities
• Identify and escalate risks
• Communicate and implement risk mitigation actions, including stock plans and redistribution
• Track Health Authority submissions and authorizations
• Manage 4–5 direct reports

• Bachelor’s degree OR Advanced degree (MS, MBA, Ph.D., PharmD) in Life Sciences, Medical Sciences, or Pharmacy
• Minimum of 7 years of industry/work experience in regulatory affairs specifically within GCC or Middle East
• Experience with diverse markets and rollout of technical change complex projects
• Understanding of the regulatory process through implementation to supply
• People management experience preferred; role will have 4–5 direct reports
• Regulatory affairs knowledge
• Structured, process-oriented, organized, and analytical skills
• Preferred experience in multiple countries or projects involving regional scope
• Flexibility and project management skills
• Teamwork and cross-collaboration
• Time management
• Patient and safety focus
• Fluency in Arabic and English, written and spoken
• Solution-oriented approach and problem-solving ability
• Good communication skills
• Ability to satisfy applicable travel and credentialing requirements, including associated vaccination prerequisites
• Valid visa/work authorization as applicable; visa sponsorship is available

• No relocation for this role
• VISA Sponsorship: Yes
• Flexible Work Arrangements
• 10% travel
• Regular employee status