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

Organon; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Organon is seeking a Regulatory Affairs Regional Project Manager (RAPM) to lead complex global regulatory change programs across 30-40 countries in the EEMEA region. You will liaise with global sourcing teams and in-country leads to ensure on-time approvals while protecting supply to patients.

Candidate will bring 7+ years of regulatory affairs experience, strong cross-functional skills, and fluency in Arabic and English. Relocation is international and visa sponsorship is provided.

Qualifications

• Regulatory affairs experience with global scope.

Responsibilities

• Manage global regulatory change projects across 30-40 countries in the EEMEA region.
• Coordinate with global sourcing management and in-country regulatory leads.
• Drive change, plan and track submissions and risk mitigation.
• Escalate risks and optimize distribution plans.
• Track HA submissions and authorizations.

Skills

Regulatory planning

Cross-functional leadership

Arabic language

English language

Project management

Stakeholder management

Education

Bachelor’s degree in Life Sciences

Advanced degree in Life Sciences

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 applicants.”

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 are 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.

Employment Details

Employee Status: Regular

Relocation: International

VISA Sponsorship: Yes

Travel Requirements: 10%

Number of Openings: 1