Especialista Regulatorio at Abbott

Santiago, Santiago Metropolitan Region, Chile

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Título universitario en Química y Farmacia, Bioquímica, Biología o carrera afín
Conocimiento de la legislación sanitaria nacional y experiencia con el ISP
Experiencia trabajando con productos biotecnológicos
Experiencia mínima de 2 a 3 años en asuntos regulatorios en la industria farmacéutica o afines
Manejo de inglés hablado excluyente

Responsibilities

Coordinar la preparación, presentación y seguimiento de expedientes para registros, renovaciones y variaciones de productos ante la autoridad sanitaria (ISP u otros organismos regulatorios)
Asegurar el cumplimiento de las normativas regulatorias locales y corporativas en todos los procesos
Mantener actualizada la base de datos de registros sanitarios, plazos y documentación regulatoria
Coordinar la comunicación con autoridades sanitarias, casas matrices y proveedores para resolver observaciones regulatorias
Apoyar en auditorías internas y externas, asegurando la disponibilidad de la documentación regulatoria
Revisar y aprobar materiales de empaque, etiquetado e información técnica de productos, garantizando la conformidad con la regulación vigente
Brindar soporte regulatorio a las áreas de calidad, supply chain, marketing y comercial
Elaborar reportes regulatorios periódicos para la gerencia y autoridades competentes

Skills

Regulatory Affairs

Product Registration

Dossier Preparation

Regulatory Compliance

Sanitary Registrations

Renewals and Variations

International Regulations

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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