Job Description

· Monitoring EAEU and National legislation updates on a regular basis, being the contact person acting on behalf of the registrant company for public health authorities.

· Responsibility for Regulatory Activities of Organon medicinal products or medical devices: timely development, submission and further support of Regulatory Dossiers related to variations.

· Acknowledgement and compliance with the reporting system adopted in Organon.
· Acknowledgement and compliance with the Company’s local regulations (SOPs).

· Compliance with the requirements for labor protection, safety, fire safety, established by the current legislation and local regulations of Organon.
· Interaction with the Company's business units (global and regional) to ensure timely regulatory support.
· Coordinate interaction with the Company's divisions (global and regional) in order to provide timely regulatory support.
· Provision reports on the registration status of products, participation in relevant meetings.
· Participation in audit preparation.
· Document, store, and archive regulatory, security, and compliance data in accordance with company policy and local requirements.
· Demonstrate the professional competencies required for this position in accordance with the level of professional development.
· Constantly develop the professional knowledge and skills that affect the efficiency of work, using all the opportunities.
 

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:

Temporary (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

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

No Travel Required

Flexible Work Arrangements:

Work Week

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R535181