Regulatory Affairs Coordinator
hace 12 horas
3866 Upjohn Export B.V. sucursal Costa Rica
At VIATRIS, we see healthcare not as it is but as it should be.
We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how the Regulatory Affairs Coordinator role will make an impact:
Job Summary:
To assist Regulatory Affairs Coordinator to provide leadership and strategic direction of specific in-country portfolio.
Key responsibilities for this role include- Coordinates and follows up on product registration concerned to ensure timely approval according to product registration plan.- Coordinates and follows up activities related to packaging artwork development, according to legal timelines, in alignment with Logistics, Marketing and product suppliers.- Maintains relevant registration licenses, regulatory affairs-related information/system, correspondence, and other relevant documentation for easy retrieval.
Ensures that they are kept current, correct, and confidential.-
- Handles correspondence with overseas and local parties (both internal and external) in order to obtain or supply required information/ documents.- Participate in meetings with BoH and Trade Associations.- Be updated regarding regulatory legislations in force and encourage the team the understanding of their contents.- Coordinate special projects.- Ensures maintenance of relevant systems according to relevant SOPs.- Ensures compliance with all relevant company SOPs.- Coordinates RA activities in partnership with Quality and Supply to ensure that their packaging, product appearance and finished product specification comply with the regulatory approval.
The minimum qualifications for this role are:
- Pharmacist degree.- Appropriate Regulatory Affairs experience - minimum 6 years is preferred.- Proven ability to consistently deliver to time, cost and quality standards.- Fluent in English - written and spoken communication skills.- Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.- Proven ability to manage regulatory issues.- Regulatory experience including knowledge of NDA submission processes and product life cycle management activities.- General management experience and previous line management and leadership experience maybe an added advantage.- Demonstrable experience of effective delivery in a complex matrix environment.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
-
Regulatory Affairs Senior Analyst
hace 12 horas
San José, Costa Rica Viatris A tiempo completo3866 Upjohn Export B.V. sucursal Costa RicaAt VIATRIS, we see healthcare not as it is but as it should be.We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access - Providing high quality trusted medicines...
-
Regulatory Affairs Development Specialist
hace 2 días
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completoJob OverviewBoston Scientific Corporation offers an exciting opportunity for a Regulatory Affairs Intern to join our team in Costa Rica. As a key member of the regulatory affairs department, you will be responsible for supporting RA Specialists with regulatory activities and learning about medical devices local regulations.Key Responsibilities• Assist RA...
-
Regulatory Affairs Specialist
hace 2 días
San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completoCompany Overview:">Boston Scientific Corporation is a leading global medical device company that empowers healthcare professionals to transform lives through innovative technologies.We're committed to delivering high-quality solutions that improve patient outcomes and advance the field of medicine.About the Role:">This role plays a critical part in our...
-
Regulatory Affairs Expert for Medicinal Products
hace 22 horas
San José, San José, Costa Rica Sandoz A tiempo completoAt Sandoz, a global leader in generic and biosimilar medicines, we're committed to pioneering access to medicines for people around the world. We believe that our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility.We're seeking a highly skilled Regulatory Affairs Coordinator to join our team in Costa...
-
Regulatory Strategy Coordinator Lead
hace 7 días
San José, San José, Costa Rica Pfizer A tiempo completoJob OverviewPfizer is committed to excellence in the field of regulatory affairs. As a key member of our team, you will play a vital role in ensuring compliance with local and international regulations.Key Responsibilities:Participate in the development and implementation of regulatory strategies for product submissions and lifecycle management.Coordinate...
-
Senior Manager, Scientific And Regulatory Affairs
hace 12 horas
San José, Costa Rica The Coca-Cola Company A tiempo completoAre you an expert in scientific and regulatory affairs with a strong advocacy mindset and robust experience within the food industry?We're looking for a proactive professional who is not only abreast of the constantly evolving regulatory landscape but is also adept at identifying potential risks and opportunities.If this sounds like you, this role could be...
-
Regulatory Affairs Specialist
hace 22 horas
San Francisco, Heredia, Costa Rica Uber A tiempo completoAbout UsAt Uber, we're redefining the way the world moves for the better. Our journey began in 2008 on a snowy night in Paris, and since then, our DNA of reimagination and reinvention has driven us to grow into a global platform moving people and things in ever-expanding ways.We tackle big problems to help drivers, riders, delivery partners, and eaters make...
-
Compliance and Regulatory Affairs Professional
hace 1 semana
San Francisco, Heredia, Costa Rica Moody'S A tiempo completoMoody's is a leading provider of credit ratings, research, and risk analysis. We are seeking a Compliance and Regulatory Affairs Associate to join our team in Heredia, Costa Rica; Lima, Peru; or Buenos Aires, Argentina.Job Summary:This junior role will support the expanding regional remit of our Compliance and Regulatory Affairs team. The Associate's...
-
San José, San José, Costa Rica Moody'S A tiempo completo**About Moody's**Moodys Government, Public and Regulatory Affairs (GPRA) team is a strategic function sitting within Corporate Affairs, which reports directly to the CEO. Our team deploys expertise on government relations, public policy, and regulatory and geopolitical analysis to inform Moodys Corporation (MCO) strategy, commercial activities and risk...
-
Regulatory Affairs Expert, San Jose
hace 4 días
San José, San José, Costa Rica Kerry A tiempo completo**About Kerry Taste & Nutrition**: At Kerry, we are leading the world to better nutrition. Our commitment drives us forward as we build and manufacture sustainable solutions for food, beverage, and pharmaceutical consumers. With 25,000+ colleagues across the globe and 15,000+ Kerry products, your opportunities are limitless.**Company Overview:** A career...
-
Regulatory Affairs Specialist
hace 4 días
San José, San José, Costa Rica Kerry A tiempo completoAbout KerryKerry is the world's leading taste and nutrition company for the food, beverage, and pharmaceutical industries. We partner with customers to create healthier, tastier, and more sustainable products consumed by billions worldwide.Our VisionWe aim to be our customers' most valued partner, creating a world of sustainable nutrition. A career with...
-
Corporate & Government Affairs Manager Caricam
hace 12 horas
San José, Costa Rica Mondelez International A tiempo completo**Job Description**:**Responsabilities**:- Develop and lead a CGA strategy and team across multiple markets, leveraging synergies where possible- Communications: Support and execute the internal and support external strategy for market/category focused reputation opportunities across the cluster.Counsel, guide and coach Market leaders communications.Drive...
-
Drug Regulatory Affairs Coordinator
hace 3 días
San José, Costa Rica Sandoz A tiempo completoMajor accountabilities: - Define the registration plan, and perform product registration activities in accordance with registration and launch plan, & maintain product licenses throughout their life-cycle, in compliance with local regulation and global strategy - Review new projects and define the plan and strategy for their submission and approval in...
-
Manager, Legal Affairs
hace 1 semana
San José, Costa Rica SBA Network Services, LLC A tiempo completo**Who We Are** SBA Communications (SBA) is an industry leader in providing the wireless infrastructure that makes communication work, with a track record of growth throughout the Americas, South Africa and Southeast Asia. Our purpose is to enable the communications that are essential in connecting people. We are listed on NASDAQ under the symbol SBAC and...
-
Regulatory Compliance Analyst
hace 1 semana
San José, Costa Rica Emerson A tiempo completo**Overall description of Position** Regulatory Compliance Analyst will work for Emerson Automation Solutions Global International Trade Compliance Shared Services, providing support to the team on administrative tasks as well as completing daily requests on behalf of Emerson Automation Solutions entities, sales offices and other locations...
-
Reg Affairs Associate
hace 12 horas
San José, Costa Rica Zimvie A tiempo completoWelcome to ZimVie, a new, publicly traded global company focused on improving quality of life for our patients.Our company is founded on a legacy of established brands, medical experts and over $1B in annual revenue.We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery and bone growth...
-
Lead Lawyer and Regulatory Affairs Specialist
hace 6 días
San José, San José, Costa Rica Sba Network Services, Llc A tiempo completo**About Sba Network Services, Llc**Sba Network Services, Llc is an industry leader in providing wireless infrastructure. Our organization has a track record of growth throughout the Americas, South Africa and Southeast Asia.We enable the communications that are essential in connecting people. We prioritize quality, uphold high moral and ethical standards,...
-
Regulatory Affairs Specialist
hace 12 horas
San José, Costa Rica Astrazeneca A tiempo completo**OBJETIVO**Planificar, implementar y monitorear las estrategias regulatorias para asegurar el mantenimiento del portafolio de los productos bajo su responsabilidad, así como para el registro de nuevos productos según las normativas vigentes en los mercados de Centroamérica y Caribe.**RESPONSABILIDADES**- Coordinar, evaluar y preparar la documentación...
-
Regulatory Affairs Specialist
hace 12 horas
San José, Costa Rica Astrazeneca A tiempo completoObjetivo:Planificar, implementar y monitorear las estrategias regulatorias para asegurar el mantenimiento del portafolio de los productos bajo su responsabilidad, así como para el registro de nuevos productos según las normativas vigentes en los mercados de Centroamérica y Caribe.**Responsabilidades**:- Coordinar, evaluar y preparar la documentación...
-
Strategic Project Coordinator
hace 4 días
San Francisco, Heredia, Costa Rica Moody'S A tiempo completo**About the Role**:Moody's, a global integrated risk assessment firm, empowers organizations to make better decisions by providing innovative solutions.As a Strategic Project Coordinator at Moody's Local, you will play a vital role in coordinating filing of regulatory reports in the region. Your responsibilities will include assisting with the...