Associate Director, Regulatory Affairs – EEMEA GAIA Project

🔥 5 minutes ago

🇦🇪 United Arab Emirates (UAE) – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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Organon

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2021

🏥 Healthcare

💼 Consulting

⚕️ Healthcare Insurance

Healthcare • Consulting • Healthcare Insurance

Organon is an independent global healthcare company with a focus on improving the health of women throughout their lives. The company has a diverse portfolio that covers women's health, biosimilars, and established brands, offering therapies for a wide array of conditions including reproductive health, cardiovascular disease, neurology, autoimmune, and respiratory conditions. Organon is active in over 150 markets worldwide and is committed to delivering medicines and devices that advance women's health at all life stages. Additionally, the company works on biosimilars to provide more accessible treatment options. Organon aims to create a brighter future and better health outcomes for women through its comprehensive healthcare solutions.

📋 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