Global Regulatory Affairs Project Manager

Job Description

The funtion

For our Global Regulatory Affairs team we are currently recruiting several candidates for the role of Regulatory Affairs Regional Project Manager.

In the role of Regulatory Affairs Regional Project Manager you will manage a global regulatory change projects with high complexity. You will work with the 30-40 countries 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

• Plan and track on-time initial submissions and RtQs (assumption to have filling plan complete);

• Confirm SKU list including deletions (timing);

• Define the complete submission packages, chase various package components;

• Continuous monthly check-ins with concerned countries;

• Request, chase and track ancillary documents (procurement);

• Standardize and harmonize documents to gain efficiency where possible;

• Identify local colliding projects and variation;

• Communicate master data updates;

• 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;

• Track artwork changes and implementation to new SKU's.

Required Education, Experience, and Skills

• Master’s degree in health (sciences), life sciences, medical sciences or another relevant field of study;

• A minimum of 10 years of industry/work experience in regulatory affairs;

• Experience with diverse markets and with the roll out of technical change projects and understand the complexity of the regulatory process up until the implementation to supply;

• You are structured, process oriented, organized and analytical;

• You have good communication skills, you are quality oriented and you do have a great eye for details;

• You are flexible, can adapt to changing priorities and you know how to operate independently as well as in a team;

• You possess good communication and time management skills and you know how to work solution oriented;

• You are ‘patient focused’ and you will always put safety first;

• You are fluent in English (written and spoken).

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:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R530089