Job Description

Ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities and – as applicable - to the China MA, designing an appropriate local ad-hoc action plan, as necessary.Ensures maintenance of authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.Participates in task forces of Agency/Pharmaceutical industry for new regulations and implementation of new ones.Maintains a positive relationship with internal and external regulatory contacts. Acts as essential point of local regulatory agency contact for the company in case of any urgent regulatory agency requests. External contacts are regulatory authorities, as well as other key players in the regulatory environment.Ensures that marketing authorizations are maintained in compliance with related regulatory areas.  Ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package, Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to company and local standards. Keeps informed with Manufacturing Organization to ensure that Prescribing Information is implemented within the correct time frames for compliance.Ensures accuracy of artwork mock-up.Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.Ensures that files and archives related to Regulatory are kept updated and complete.Provides regulatory representation for GCP and PV inspection teams and ensure that the regulatory components are addressed.

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:

No 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:R533447