Regulatory Affairs Specialist
hace 2 días
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 everyday. 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) Employee Status: RegularRelocation: DomesticVISA Sponsorship: NoTravel Requirements: NoneFlexible Work Arrangements: NoneShift: N/AValid Driving License: N/AHazardous Material(s): NoneNumber of Openings: 1Requisition ID: R 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. #J-18808-Ljbffr
-
Regulatory Affairs Specialist
hace 2 semanas
Buenos Aires, Argentina Prometeo Talent A tiempo completoRegulatory Affairs Specialist – Regulatory Affairs / Southern Cone At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more...
-
Hybrid Regulatory Affairs Specialist
hace 2 semanas
Buenos Aires, Argentina Medtronic plc A tiempo completoA global medical technology leader is seeking a Regulatory Affairs Specialist in Buenos Aires. This position requires a bachelor's degree in relevant fields and fluency in English, with over two years of regulatory affairs experience. The role involves direct coordination for regulatory submissions, compliance recommendations, and monitoring of regulatory...
-
Regulatory Affairs Specialist
hace 2 semanas
Buenos Aires, Argentina ABB A tiempo completoCareers that Change Lives In this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross‑functional business partners under your responsibility. You will provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or...
-
Regulatory Affairs Specialist – MedTech
hace 2 semanas
Buenos Aires, Argentina Medtronic A tiempo completoA leading medical technology company is seeking a Regulatory Affairs Specialist to oversee coordination for regulatory submissions and ensure compliance in medical devices. Located in Argentina, the position offers a hybrid work model. The ideal candidate requires a Bachelor's degree in a relevant field and must have 2+ years of experience in regulatory...
-
LATAM Regulatory Affairs Specialist – Packaging
hace 2 semanas
Buenos Aires, Argentina Prometeo Talent A tiempo completoA leading healthcare company is looking for a Regulatory Affairs Specialist in Buenos Aires. The role involves managing regulatory activities for product registrations and artwork requests across South America. Candidates should have a degree in Pharmacy, Biochemistry, or similar fields, and advanced English proficiency. Join a dynamic team that values...
-
Senior QA
hace 2 semanas
Buenos Aires, Argentina Spirax Sarco A tiempo completoA leading medical technology company in Buenos Aires is hiring a Sr. RAQA Specialist. This role involves supporting Quality Assurance and Regulatory Affairs, focusing on compliance with local regulations. Responsibilities include managing product labeling, overseeing audits, and maintaining quality systems. Candidates must have a Bachelor's degree and...
-
LATAM Regulatory Affairs Leader
hace 2 semanas
Buenos Aires, Argentina ABB A tiempo completoA leading technological company in Buenos Aires is seeking a Regulatory Affairs Specialist to lead and manage regulatory activities for Latin America. The ideal candidate will have a BA/BS degree in a related field and at least 2 years of experience in Regulatory Affairs within medical devices or the pharmaceutical industry. Proficiency in Spanish and...
-
Senior LATAM Regulatory Affairs Specialist
hace 3 semanas
Buenos Aires, Argentina Directa24 A tiempo completoA global healthcare company is searching for a Regulatory Affairs Sr Specialist to consult on documentation for submissions across LATAM markets. The role requires 3-4 years of experience in the regulatory environment and knowledge of LATAM regulations. Applicants should hold a Bachelor’s degree in life sciences. The position involves preparing...
-
Experienced Regulatory Affairs Specialist
hace 7 días
Buenos Aires, Buenos Aires C.F., Argentina Johnson & Johnson Innovative Medicine A tiempo completoAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Experienced Regulatory Affairs Specialist
hace 7 días
Buenos Aires, Buenos Aires C.F., Argentina Johnson & Johnson A tiempo completoAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
