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

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 escalate 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. 

Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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