Job Description

Responsibilities

• Drive product registration plans and strategies and work cross-functionally to review and communicate the registration strategy with management oversight.

• Timely preparation, submission of post-market regulatory dossiers including but not limited to variations, renewal applications and supplemental marketing authorization in accordance with local regulations and global standards including support GAIA projects under responsible Phuchayhaa Therapeutic area.

• Coordinate with POHO team for archiving and maintenance of regulatory data and documentation in accordance with department and company policies and local requirements

• Coordinate with artwork team (Flyer) to develop artwork and responsible to check and comply as local HA approval.

• Work collaboration with supply to communicate and participant supply meeting (if any).

• Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.

• As delegated, ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirement.

• Support activities as assigned by Head of RA.

• Contact HA as related responsible task.

• Have experience 4-5 years in RA.

• Good communication (reading, writing and listening). Be able communication in English to global team and participant in meeting.

• Well acknowledge in eCTD submission including preparation and support global query.

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:

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