Assoc. Dir, Regulatory Affairs - EEMEA GAIA Project (remote)

Organon LLC; Dubai; Remote; AED 320,000 - 520,000; Full time

Job summary

Organon LLC in Dubai seeks a Regulatory Affairs Regional Project Manager (RAPM) to lead global regulatory change projects across 30-40 countries in EEMEA, ensuring on-time approvals and uninterrupted supply. You will liaison between global sourcing and in-country regulatory leads, work with regional regulatory and CMC teams, drive changes, and deliver solution-oriented outcomes.

Required: 7+ years in regulatory affairs in GCC/Middle East, Bachelor’s or higher in Life Sciences, fluent Arabic and

Qualifications

• Bachelor’s or advanced degree in Life Sciences or related field.
• Minimum 7 years in regulatory affairs in GCC/Middle East.
• Experience with regional/regulatory project rollout.
• Team leadership experience preferred.

Responsibilities

• Change management.
• Plan and track on‑time initial submissions and RTQs (assumption to have filling plan complete).
• Escalate shifts from the plan and bundling opportunities.
• Identify and escalation any identified risk.
• Communicate and action risk mitigation (e.g. stock plans, re‑distribution).
• Track Health Authority (HA) submission and authorizations.

Skills

Regulatory affairs

Project management

Team leadership

Bilingual Arabic/English

Education

Bachelor’s degree in Life Sciences

Advanced degree (MS, MBA, Ph.D., PharmD)

Job description

Job Description Position

In the role of Regulatory Affairs Regional Project Manager (RAPM), you will manage a global regulatory change projects with high complexity. You will work with 30-40 countries within EEMEA to facilitate on‑time regulatory approvals and making sure the changes do not impact supply to our patients. You will be the liaison between the global sourcing management team and the in country regulatory leads. You will closely work with your regional counter parts across the globe within regulatory and CMC to improve the processes. You are a driver of change, and you are expected to work solution oriented.

Responsibilities

• Change management.
• Plan and track on‑time initial submissions and RTQs (assumption to have filling plan complete).
• Escalate shifts from the plan and bundling opportunities.
• Identify and escalation any identified risk.
• Communicate and action risk mitigation (e.g. stock plans, re‑distribution).
• Track Health Authority (HA) submission and authorizations.

Required Education, Experience and Skills

• Bachelor’s degree OR Advanced degree (MS, MBA, Ph.D., PharmD) – Life Sciences, Medical Sciences, Pharmacy.
• A minimum of 7 years of industry/work experience in regulatory affairs specifically within GCC or Middle East. Experience with diverse markets and with the roll out of technical change complex projects and understanding the complexity of the regulatory process up until the implementation to supply.
• People Management is preferred - this role will have 4-5 direct reports.
• Regulatory affairs
• Structured, process oriented, organized, and analytical skills.
• Preferred experience in multiple countries or projects involving regional scope.
• Flexibility & project management skills
• Teamwork & Cross collaboration is essential.
• Time management
• Patient and safety focused.
• You are fluent in Arabic & English (written and spoken).
• Solution - oriented approach and can solve problems.
• Good communication skills
• There is no relocation for this role.

"Although one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicant."

Secondary Job Description

Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and do to growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Annualized Salary Range Annualized Salary Range (Global) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country. Employee Status: Regular Relocation: International VISA Sponsorship: Yes Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites 10% Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.