**Job Description**: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!**Main Responsibilities**:Responsible for all Pharmacovigilance and Regulatory Affairs submission requirements and Pharmacovigilance activities for their assigned product portfolio according to Organon policies and procedures in Central America and Caribbean countries, as applicable.The Senior Specialist is the regulatory contact with local stakeholders and headquarters and is the direct contact for health authority submission specific topics.The Senior 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.**Competencies****Knowledge**:- Central America & Caribbean countries legal regulations- Regulatory and Pharmacovigilance activities- Leadership behaviors**Languages**:- Spanish- English (Reading, writing and speaking) -advanced level**Skills****(professional and/or technical)**- Proficient in MS Office software- Attention to detail- Ability to work cross-functionally in pharmaceutical company environment- Time management, Good self-organization, creativity and initiative.- Flexible, Team-player, Accurate- Effective communication skills (both written and oral).- Ability to transmit knowledge to others**Experience**- 4 to 8 years in Regulatory Affairs at Pharmaceutical Industry- Good knowledge of ICH, GMP and local regulations.- +3 years in similar positions.**Education / Certificates**Pharmacist or related sciences**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.**Search Firm Representatives Please Read Carefully****Annualized Salary Range****Employee Status**:Regular**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**Requisition ID**:R518189
