Specialist, Regulatory, Shared Service Delivery
hace 2 semanas
e:
Renewals, Deletions, Mergers, Acquisitions, Transfers, Legal Entities changes, Site name changes, Tender Bids, labeling activities and artwork implementation) are planned, managed, and executed timely and accurately, issues are identified and resolved, and opportunities for improvement of the business processes are pursued.
- NOTE: Other locations beyond what is listed will be considered for this position _
e:
- Supports Regulatory Associate Director and team with the regulatory impact assessment, overall planning, validation of change scope and regulatory intelligence.
- Partners very closely with Country Regulatory Affairs and the Outsourcing Partner (for some processes) during the planning and execution of the business process or a project to collect necessary inputs for the accurate planning, validates country specific requirements.
- Participates in the country or subregional (project) meetings to ensure alignment between country and regional or global stakeholders.
- Acts as the global Artwork point of contact between the CRA's and the Artwork Center to coordinate the AW implementation process (including regulatory management of the bundled changes and the shared packs)
- Forecasting of Artwork volume and planning
- Monitors the regulatory execution milestones (e.g HA submissions and approvals), facilitates the necessary followups and escalations cross functionally and cross divisionally, as applicable.
- Prepares the metrics for the designated business process.
- Reports monthly and quarterly project updates by using the designated communication dashboards.
- Prepares high quality labeling, artwork packages, and conducts assessments of captioning and artwork management. These activities are aimed at supporting the timely submission of new Marketing Authorization Applications, variations, and supplementary marketing authorizations. These tasks are associated with labeling and artworks activities. Partnering with local CRAs to be able to submit to local authorities, maintains local files, updates tracking systems, databases, and handles minor translations.
Secondary Language(s) Job Description**:
Education:
Bachelor's or master's degree preferred or equivalent work experience in life science, engineering, business or a related field (ideally pharmaceutical science degree)
Requirements:
- Minimum 23 years' experience in pharmaceutical industry
- Previous experience in Regulatory, CMC or Quality is preferred.
- Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
- Strong interpersonal skills and capacity to work across the geographies with the high number of stakeholders.
- Detail oriented
- Ability to communicate effectively, both verbally and written, with others across all levels of the organization
- Ability to work in a matrix organization.
- Competent user of Microsoft Office
- Technology proficient; Interest in new tools or automatization will be needed.
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:
R287525
-
Bogotá, Bogotá D.E., Colombia MSD A tiempo completoJob DescriptionThe Shared Service Delivery Model Director role reports to the Sr Director and will be responsible to ensure the delivery of all regulatory milestones related with strategy, planning, development, submission, registration, approval, and life cycle maintenance of Pharmaceutical Products Registration in compliance with our company standards and...
-
Regulatory Affairs Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Johnson & Johnson A tiempo completoJohnson & Johnson Vision, a member of Johnson and Johnson's Family of Companies, is recruiting for a Regulatory Affairs Specialist located preferably in Colombia, or Mexico. An exciting opportunity to join a diverse team.At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That's why, through our operating companies,...
-
Regulatory Affairs Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia ABBVIE A tiempo completoJoin us at AbbVie, where medicine, aesthetics, and science are powered by some of the brightest minds in the world.We're a dynamic biopharmaceutical company that offers you the resources you need and a global reach that empowers your innovative mindset. From day one, we've known it takes teamwork, passsion, and culture built on diversity and inclusion to...
-
Regulatory Affairs Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia ARIAD A tiempo completoREGULATORY AFFAIRS SPECIALIST:Bogotá, Bogota D.C.Job ID R0117127Category Research & DevelopmentSubcategory Research & DevelopmentBusiness Unit Global Portfolio DivisionJob Type Full timeRegulatory Affairs Specialist_ Versión Español_PROPOSITO DEL ROLEste rol es responsable de apoyar el plan estratégico del negocio para obtener autorizaciones de...
-
Customer Service Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Philips A tiempo completoJob Title: Customer Service Specialist - BogotáCustomer Service Specialist, BogotáIn this role, you'll have the opportunity to make life better, by interacting with customers, company sales and/or service team to handle a variety of pre-sales or post sales service functions.Your role: Lead the implementation of Lean tools such as Daily Management and...
-
Regulatory Affairs Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Takeda Pharmaceutical A tiempo completoRegulatory Affairs Specialist_ Versión Español_PROPOSITO DEL ROLEste rol es responsable de apoyar el plan estratégico del negocio para obtener autorizaciones de comercialización y variaciones, tanto para productos existentes como nuevos. Además, coordinará las actividades de Excelencia Regulatoria en Colombia asegurando el cumplimiento de los...
-
Service Delivery Lead
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Neoris A tiempo completoEn NEORIS es un acelerador Digital que ayuda a las compañías a entrar en el futuro, teniendo 20 años de experiencia como Socios Digitales de algunas de las mayores compañías del mundo.Somos más de 4,000 profesionales en 11 países, con nuestra cultura multicultural de startup en donde cultivamos innovación, aprendizaje continuo para crear soluciones...
-
Regulatory Affairs Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Johnson & Johnson A tiempo completoAt 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 than 1 billion patients and consumers every day for more than 130...
-
Regulatory Affairs Specialist, Latam
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Novasyte A tiempo completoPOSITION TITLE:Regulatory Affairs SpecialistREPORTS TO:Manager, Regulatory Affairs or DesigneeBASIC FUNCTIONS:ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance, training,...
-
Regulatory Affairs Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoRequisition Number: AMER27699Employment Type: Full-timeLocation: BogotaJob Summary: Responsible for assisting the team with regulatory change assessments and filings as necessary to market and maintain Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as a understanding of the regulatory...
-
Regulatory Affairs Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to...
-
Service Delivery Lead
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Neoris A tiempo completoEn NEORIS es un acelerador Digital que ayuda a las compañías a entrar en el futuro, teniendo 20 años de experiência como Socios Digitales de algunas de las mayores compañías del mundo. Somos más de 4,000 profesionales en 11 países, con nuestra cultura multicultural de startup en donde cultivamos innovación, aprendizaje continuo para crear soluciones...
-
Regulatory Operations Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo**Careers that Change LivesA role in MCRS offers unique experience opportunities, such as being part of a global team, collaborating with business partners throughout the company, visibility to global structures and impacts, and insight to various processes and functions across Medtronic.We believe that when people from different cultures, genders, and...
-
Service Delivery Lead
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Neoris A tiempo completoEn NEORIS es un acelerador Digital que ayuda a las compañías a entrar en el futuro, teniendo 20 años de experiência como Socios Digitales de algunas de las mayores compañías del mundo. Somos más de 4,000 profesionales en 11 países, con nuestra cultura multicultural de startup en donde cultivamos innovación, aprendizaje continuo para crear soluciones...
-
Trade Service Professional Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Citi A tiempo completoBUSINESS OVERVIEWAmericas Trade Services is a key unit within the Global Trade Operations, with servicing responsibilities for a group of several trade products to Latin America, supporting several Citigroup businesses. Global Trade Operation offers world class trade services in over 70 markets around the globe. The Colombia-based organization supports North...
-
Regulatory Affairs Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Reckitt A tiempo completo¿Quieres llevar tu carrera de Asuntos Regulatorios a otro nível en una multinacional de consumo masivo? como Regulatory Affairs Specialist para la línea de Nutrición podrás tener la libertad de innovar y proponer para asegurar nuestro crecimiento y aterrizar nuestras nuevas ideas.El objetivo del cargo es:Manejar el portafolio de productos de Nutrición...
-
Chief of Section, Service Delivery
hace 2 semanas
Bogotá, Bogotá D.E., Colombia United Nations A tiempo completoThis position of Chief Service Delivery is located under the Office of the Chief of Mission Support (OCMS) in the United Nations Verification Mission in Colombia (UNVMC). The incumbent will report to the Chief of Mission Support (CMS).Responsibilities:Within the delegated authority, the Chief Service Delivery P-5 is responsible for the following...
-
Customer Service Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Johnson & Johnson A tiempo completoAt Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That's why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly based healthcare company, we are committed to using our reach and size for good....
-
HR Shared Services Specialist-required Portuguese
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoRequisition NumberAMER27925Employment TypeFull-timeLocationBogotaJob Summary: The HR Shared Services Specialist role is a customerfacing position located within the HR shared services center and is responsible for handling employee inquiries and entering transactions into the HRIS system in a timely and accurate manner and acts as a steward of the existing...
-
Application Service Delivery Manager
hace 2 semanas
Bogotá, Bogotá D.E., Colombia GM Financial A tiempo completoOverview:Responsibilities: Work with relevant Release Manager(s) to ensure defect & bug fixes, nonfunctional system changes, patches and upgrades are prioritized and planned into block releases and deployed in an efficient and timely manner. Review all Changes and Releases ready for approval into Pre production and then to Production Take part in the team...