Regulatory Affairs Specialist
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
Responsible for all Regulatory Affairs submission requirements for their assigned product portfolio according to Organon policies and procedures in Andean Cluster Countries -Argentina-, as applicable. The Specialist is the regulatory contact with local stakeholders and headquarters and is the direct contact for health authority submission specific topics.
The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.
- 3 to 5 years in Regulatory Affairs at Pharmaceutical Industry
- Good knowledge of ICH, GMP and local regulations.
- +3 years in similar positions.
Biosimilars regulation knowledge
Andean Cluster countries pharmaceutical legal regulations -mainly Argentina- . Medical Devices and In-vitro Diagnostic Reagent regulations desirable
- Regulatory activities
- Leadership behaviors
- Pharmacovigilance (desirable)
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.
At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion. At Organon, we all belong. We embrace diversity and give it a voice.
Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.
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.
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Flexible Work Arrangements:
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Number of Openings:1