Specialist, Regulatory Affairs ( Fixed Term 6 months)

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.

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.

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Please, no phone calls or emails.

Annualized Salary Range

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):

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.