Global Regulatory Affairs Specialist
hace 3 días
Job Summary:
The Regional Submission Coordinator plays a critical role in supporting affiliate regulatory and business alliance partnerships in emerging markets within the International Region, with a focus on Latin America.
This position requires strong technical expertise in Veeva Vault RIM system and experience with global regulatory business processes.
Key Responsibilities:
- Serve as Subject Matter Expert (SME) for global regulatory business processes and Veeva Vault RIM system execution.
- Support affiliate regulatory and alliance partnerships with Veeva Vault RIM submission management.
- Monitor, manage, and execute country post-approval submission plans by providing a submission-ready dossier and performing related system updates and maintenance.
RIM Content Planning:
- Support Affiliate Regulatory/Alliance Managers with RIM content planning for all submission types.
- Match appropriate documents to the RIM content plan, send content plan for review, and lock and confirm the top-level content plan when complete.
- Send notification for export to Affiliate Regulatory/Alliance Managers and/or eCTD publisher.
Post-Approval Submission Coordination:
- Manage the post-approval submission agenda for all products in assigned countries/regions, monitoring post-approval submission plans and workload to achieve planned submission dates.
- Collaborate with Lilly Affiliate Regulatory and Alliance Managers/Associates and directly interact with external alliance business partners and liaise with cross-functional partners to achieve optimal post-approval submission plans, ensuring compliant product availability.
- Create RAPT/RIM Renewal and Manufacturing Site Registration/Renewal records and maintain planned/target/actual submission and approval dates for all post-approval activities in collaboration with the Affiliate/Alliance Manager.
Affiliate Regulatory RIM System Support:
- Ensure affiliate regulatory teams are appropriately supported with RIM system training and technical assistance.
Requirements:
- Strong technical expertise in Veeva Vault RIM system.
- Excellent analytical and problem-solving skills.
- Effective communication and interpersonal skills.
- Able to work effectively in a fast-paced environment.
What We Offer:
- Competitive compensation and benefits package.
- Ongoing professional development opportunities.
- Diverse and inclusive work environment.
-
Regulatory Affairs Specialist
hace 4 días
San José, San José, Costa Rica Sc Johnson A tiempo completoAbout the Role:SC Johnson is a global company built on the spirit of our people. With over 130 years of history, we have established ourselves as a leader in the industry, creating iconic brands that win the hearts and minds of consumers worldwide.We are seeking a highly skilled Regulatory Affairs Specialist to join our team. In this role, you will be...
-
Regulatory Affairs Analyst
hace 3 horas
San José, San José, Costa Rica Pfizer A tiempo completoJob Overview:We are seeking a highly skilled Regulatory Affairs Analyst to join our team. In this role, you will be responsible for ensuring that Pfizer's regulatory affairs activities are conducted in compliance with relevant laws and regulations.You will work closely with cross-functional teams to review and analyze regulatory documents, identify areas of...
-
Regulatory Affairs Specialist Lead
hace 5 días
San José, San José, Costa Rica The Coca-Cola Company A tiempo completoAbout the RoleWe are seeking a highly experienced Senior Compliance Officer to join our team in Latin America. As a key member of our Scientific & Regulatory Affairs function, you will play a critical role in enabling business growth through regulatory compliance and innovation.
-
Regulatory Affairs Specialist
hace 5 días
San José, San José, Costa Rica Pfizer A tiempo completoKey Activities:The successful candidate will contribute to the completion of moderately complex projects, leveraging their regulatory knowledge to produce high-quality labeling materials.They will utilize their expertise to ensure that all labeling-related documentation is accurate, compliant, and meets the required standards.In addition, they will provide...
-
Global Regulatory Compliance Specialist
hace 2 días
San José, San José, Costa Rica Zimvie A tiempo completoAbout the JobWe are seeking an experienced Reg Affairs Associate to assist our team with regulatory filings as necessary to market Zimmer Biomet products.This is an entry-level position, providing training towards full competency in Regulatory Affairs (RA).The ideal candidate will have a basic understanding of medical devices and their use, as well as a...
-
Regulatory Affairs Intern
hace 2 semanas
San José, San José, Costa Rica Boston Scientific Corporation A tiempo completo**Work mode**:**Onsite Location(s)**:San José, H, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**- At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most...
-
Senior Manager, Scientific And Regulatory Affairs
hace 2 semanas
San José, 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...
-
Compliance Specialist
hace 6 días
San José, San José, Costa Rica Medtronic A tiempo completoAbout MedtronicWe're a leading medical technology company that's changing healthcare worldwide. Our mission is to improve lives through innovative technologies and therapies. We're committed to accelerating and advancing our ability to create meaningful innovations, and we need talented individuals like you to help us achieve this goal.Job DescriptionThe...
-
International Regulatory Manager
hace 7 días
San José, San José, Costa Rica Mondelez International A tiempo completo**Key Skills and Qualifications**To succeed in this role, you will need strong networking and communication skills, reliability, accuracy, and an efficient work style.You should be able to meet deadlines, attend to detail, manage projects, and have experience in regulatory affairs in an international and multi-functional environment.A desire to drive your...
-
Document Submission Expert
hace 6 días
San José, San José, Costa Rica Medtronic A tiempo completoCareer OpportunitiesWe're a global company with a diverse range of career opportunities. As a Regulatory Affairs Specialist, you'll work closely with cross-functional teams to ensure compliance with regulatory requirements.About the RoleThe Regulatory Affairs Specialist will be responsible for:Coordinating and preparing document packages for regulatory...
-
Regulatory Affairs Coordinator
hace 6 días
San José, San José, Costa Rica Medtronic A tiempo completoCareers that Change LivesA Day in the LifeOur team is responsible for coordinating and preparing document packages for regulatory submissions. Key responsibilities include:Directing or performing coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.Leading or compiling...
-
Manager, Legal Affairs
hace 4 días
San José, 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 our...
-
Packaging Labeling Specialist
hace 6 días
San José, San José, Costa Rica Asepsa A tiempo completoASOCIACIÓN SOLIDARISTA DE EMPLEADOS DE PFIZER Y AFINESIS LOOKING FOR APACKAGING & LABELING SPECIALIST**ROLE SUMMARY**Colleague fundamentally performs the ePALMS system "Market Coordinator" (MC) role in closecollaboration with the Global Regulatory Affairs (GRA) Strategy functions and is the centralRegulatory point of contact for the PGS plants/Artwork...
-
Regulatory Compliance Specialist
hace 1 día
San José, San José, Costa Rica Genpact A tiempo completoJob Description:We are seeking a highly skilled and detail-oriented Regulatory Compliance Specialist to join our team. As a key member of our compliance team, you will be responsible for ensuring that our products meet all relevant regulatory requirements.Responsibilities:Evaluate complaints for severity and risk to public safetyIdentify and confirm...
-
Regulatory Affairs Professional
hace 5 días
San José, San José, Costa Rica Pfizer A tiempo completoIn this role, you will be part of our team responsible for ensuring compliance with MAPP policy and other regulatory requirements across various geographies.
-
Regulatory Compliance Auditor, Global Regulatory
hace 2 semanas
San José, San José, Costa Rica Amzn Support Srvcs Costa Rica A tiempo completo2+ years Seller Support experience- 1+ year on Compliance, Audit or Risk roles and Project/Program Management experience- Demonstrated strong analytical skills; including the ability to find, interpret, and make recommendations based on available data.- Demonstrated experience dealing with competing priorities in a fast-paced, deadline-driven environment.-...
-
Regulatory Affairs Specialist
hace 10 horas
San José, San José, Costa Rica Boston Scientific Corporation A tiempo completo**Company Overview**Boston Scientific Corporation is a leading global medical technology company that shapes medical innovation for life. We develop, manufacture and market medical devices to improve the health of patients around the world.Our products are used in a wide range of medical specialties, including cardiology, oncology, neurology, urology and...
-
Reg Affairs Associate
hace 1 semana
San José, 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...
-
Corporate & Government Affairs Manager Caricam
hace 2 semanas
San José, 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...
-
Regulatory Compliance Analyst
hace 4 días
San José, 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 globally.Regulatory...