Job Description

About the role

The RA Specialist will be responsible for supporting Regulatory Affairs activities in North Macedonia and other markets of East Europe. The RA Specialist will collaborate with colleagues in these markets to ensure compliance with local laws and regulations, including backing up colleagues.

RA Specialist will be working in an inclusive environment and fostering collaboration with RA colleagues. This is a role with opportunity for both personal and professional growth. It is a great time to join our team as it grows and evolves.

Main Activities

Execution of country RA processes and activities in alignment with RA systems and their associated Quality Management System, following company and department SOPs, company Policies and Procedures and country legislation.

Timely preparation and submission of new Marketing Authorization Applications to local Health Authorities, life-cycle management of authorized products and post approval activities, including but not limited to artwork management.

Filing, storage and archiving safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.

Support in local RA audits and inspections including readiness activities, support with audits of contractual partners/vendors as necessary and support with other audits/inspections activities including the development of CAPAs in response to findings/observations.

Support with drug shortage management and regulatory requirements for reporting, including cross-functional collaboration.

Role requirements and qualifications:

Health, life science, pharmaceutical or medical science degree or equivalent by education

Language: mother tongue/certified proficiency Macedonian

Advanced English

Advanced knowledge of any other Eastern European (EU or non-EU) language will be considered an advantage

App. 2 years of industry experience in regulatory affairs

General knowledge of EU RA regulations and RA processes/activities

Good communication and time management skills

Capability to work under pressure and meet deadlines

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:

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:

Requisition ID:R533489