Associate Director, Regulatory Affairs – EEMEA GAIA Project

Job Description:

  • 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

Requirements:

  • 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

Benefits:

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