Global Regulatory Submissions Manager
hace 1 mes
SAO Fortrea Brazil Limitada is seeking a highly skilled Global Regulatory Submissions Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for overseeing and ensuring the compliance of regulatory submissions, including submission strategy, timeline planning, and delivering to agreed-upon timelines.
Key Responsibilities- Develop and implement submission strategies to ensure timely and compliant regulatory submissions.
- Collaborate with cross-functional teams to ensure regulatory compliance and adherence to client requests.
- Provide high-quality advice on regulatory issues to project teams and clients, maintaining awareness of current regulatory legislation and guidance.
- Manage user access to CTIS and provide regulatory expertise on the application of the EU CTR in CTIS.
- Review and input into required start-up project plans, ensuring compliance to regulatory requirements.
- Proactively identify and escalate risks to meeting deliverables, managing projects according to the billing guide.
- Engage in quality assurance and risk management activities to ensure project deliverables are met.
- 7-10 years' experience in the pharmaceutical industry or drug development in regulatory affairs.
- Excellent communication, organization, and planning skills with an attention to detail.
- Extensive experience in leading clinical trial applications at a regional/global level.
- Direct project management skills and ability to work independently.
- Understanding of and ability to determine relevance of governmental regulatory processes and regulations.
- Bachelor's degree or higher.
- Fluency in English.
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Regulatory Strategy Coordinator
hace 3 semanas
San José, San José, Costa Rica Pfizer A tiempo completoJob DescriptionJob Title: Regulatory Strategy CoordinatorJob SummaryThe Regulatory Strategy Coordinator will play a key role in the planning and execution of regulatory strategies for products submissions and lifecycle management. This includes coordinating activities related to dossier planning and submission, interacting with internal stakeholders, and...
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Regulatory Affairs Specialist Trainee
hace 3 semanas
San José, San José, Costa Rica Boston Scientific Corporation A tiempo completoJob SummaryWe are seeking a highly motivated and detail-oriented Regulatory Affairs Intern to support our team in San José, Costa Rica.About the RoleAs a Regulatory Affairs Intern, you will work closely with our RA Specialists to learn and assist with regulatory activities in Central America. Your responsibilities will include:Supporting RA Specialists with...
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Regulatory Affairs Director
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Global Quality Assurance Manager
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San José, San José, Costa Rica Amazon Support Services Costa Rica Srl - B20 A tiempo completoAbout this RoleWe are seeking a highly skilled Quality Control Manager to lead our global team of Quality Specialists in the Know Your Customer programme. This role will manage a team of approximately 7 people responsible for auditing and reporting high-complexity AML operational work across Amazon's payment entities and licenses.Key...
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Risk Manager for Regulatory Compliance
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Regulatory Compliance Specialist, Central America
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San José, San José, Costa Rica Sc Johnson A tiempo completoAt SC Johnson, we're committed to building a better future for our planet, our people, and our communities. As a Regulatory Compliance Specialist, Central America, you'll play a critical role in ensuring our products meet the highest standards of quality and safety in the region.Key Responsibilities:- Maintain compliance with relevant regulations, standards,...
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Global Operations Manager
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Regulatory Affairs Director
hace 2 semanas
San José, San José, Costa Rica The Coca-Cola Company A tiempo completoJob OverviewWe are seeking a highly skilled Regulatory Affairs Director to join our team at The Coca-Cola Company. In this role, you will be responsible for providing expert guidance on regulatory affairs and ensuring compliance with global regulations.
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Regulatory Compliance Specialist
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Regulatory Affairs Specialist
hace 4 semanas
San José, San José, Costa Rica Kerry A tiempo completo**About Kerry**:Kerry is a leading global taste and nutrition company that partners with customers to create healthier, tastier, and more sustainable products. Our vision is to be our customers' most valued partner, driving innovation and growth in the food industry.**About the Role**:As a Regulatory Affairs Specialist, you will be responsible for ensuring...
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Regulatory Compliance Specialist
hace 1 mes
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Client Relationship Manager
hace 6 días
San José, San José, Costa Rica Wns Global Services A tiempo completoAt WNS Global Services, we are committed to delivering exceptional client experiences. As a Client Relationship Manager - Global Operations, you will play a critical role in achieving this goal.We are seeking an experienced professional with a proven track record of success in contact center and customer relationship management. The ideal candidate will...
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Scientific and Regulatory Affairs Director
hace 3 semanas
San José, San José, Costa Rica The Coca-Cola Company A tiempo completoWe're seeking a seasoned professional to lead our Scientific and Regulatory Affairs efforts in Latin America.As our ideal candidate, you'll bring 7-10 years of experience in the food industry, with a strong background in regulatory affairs and advocacy.Key responsibilities will include:Providing regulatory expertise and guidance to ensure compliance with...
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Global Localization Manager
hace 3 semanas
San José, San José, Costa Rica Amazon Support Services Costa Rica Srl A tiempo completoJob Title: Program ManagerAbout the Role:Selling Partner Developer Services is seeking a Localization Program Manager to oversee global multi-lingual localization projects in a dynamic digital environment.Key Responsibilities:Oversee end-to-end international localization projects, closely collaborating with internal business partners, external vendors, and...
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Senior Regulatory Affairs Specialist
hace 1 semana
San José, San José, Costa Rica Kerry A tiempo completoAbout Kerry:Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Our mission is to create healthier, tastier and more sustainable products that are consumed by billions of people across the world.**Key Responsibilities:**Specialist in Regulatory Affairs - high expertise in allergens, GMO, labels,...
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Sr. Risk Manager, Seller Experience, Regulatory
hace 4 semanas
San José, San José, Costa Rica Amazon Support Services Costa Rica Srl A tiempo completoJob Summary:Degree in computer science, engineering, finance, economics, or other related field. 5+ years of program/project management experience in technology-focused business. Knowledge of SQL and experience in creating own measurements. Ability to think critically to propose solutions using data. Team spirit and willingness to roll up sleeves to solve...
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Global Sales Manager
hace 4 semanas
San José, San José, Costa Rica Amazon Support Services Costa Rica Srl A tiempo completoJob SummaryWe are seeking a highly skilled Global Sales Manager to join our team at Amazon Support Services Costa Rica Srl. As a Global Sales Manager, you will be responsible for managing and growing a portfolio of key accounts across Japan and Australia, driving improvements across a range of selling and expansion-related fields.Key...
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Restaurant Operations Manager
hace 1 semana
San José, San José, Costa Rica D.C. Global Talent Inc. A tiempo completoJob OverviewD.C. Global Talent Inc. is seeking a highly skilled Restaurant Operations Manager to oversee the day-to-day operations of our multi-outlet establishments.About the RoleThis key position will be responsible for leading a diverse team, developing operational policies, collaborating with the culinary team, and maintaining high service standards and...
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Operations Manager I
hace 4 semanas
San José, San José, Costa Rica Pk Global A tiempo completoOperations Manager I Job DescriptionAt Pk Global, we are seeking an experienced Operations Manager I to join our team. This key role will be responsible for coaching and supervising a group of Team Leaders, ensuring Client Service Level Agreement and financial expectations are achieved.Key Responsibilities:Analyze and maintain all Client Service Level...
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Senior Event Operations Manager
hace 1 semana
San José, San José, Costa Rica Pfizer A tiempo completoJob DescriptionWe are seeking a highly skilled Senior Event Operations Manager to join our team at Pfizer. The ideal candidate will have extensive experience in virtual event planning, production, and technical support.The successful candidate will lead the coordination of local Virtual Event Services team at Costa Rica Village site, ensuring seamless...