Specialist Regulatory Affairs

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!

About the role: The RAaPV Specialist will be responsible for supporting Regulatory Affairs activities in Mexico. The RA Specialist will collaborate with colleagues in this market 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 RAaPV 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.

• Execution of country RA processes and activities in alignment with RA systems and their associated Quality Management System, following 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, in accordance with local regulations and global standards as assigned product.
• Filing, storage and archiving regulatory data and documentation in accordance with department and company policies and local requirements.
• Support with drug shortage management and regulatory requirements for reporting, including cross-functional collaboration.
• Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
• Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality RA data and evaluates processes for potential improvement in efficiency and effectiveness.
• Support assigned project from Manager or RAPV Lead if applicable.
• Contributes in the maintenance of regulatory licenses for Therapeutic Products and Medical Device.

Education Minimum Requirements

• Health, life science, pharmaceutical, pharmaceutical engineers, biochemical engineers or chemists-pharmacists-biologists degree or equivalent by education
• Effective communication skills in Spanish and English, spoken and written

Required Experience and Skills

• +3 years of industry experience in regulatory affairs
• General knowledge of local regulations and RA processes/activities
• Some experience interacting/ communicating with regulatory authorities
• Good communication and time management skills
• Capability to work under pressure and meet deadlines

Preferred Experience and Skills. 

• Leadership, negotiating and planning skills
• Teamwork
• Proactive to research
• Focused on results and conflict resolution
• Strategic thinking

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.