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

Key technologies and capabilities for this role

Regulatory AffairsProduct RegistrationDossier PreparationRegulatory ComplianceSanitary RegistrationsRenewals and VariationsInternational Regulations

Questions & Answers

Common questions about this position

What is the location for this position?

The position is located at our production plant in the commune of Quinta Normal.

What qualifications are required for the Regulatory Specialist role?

A university degree in Chemistry and Pharmacy, Biochemistry, Biology or related field is required, along with knowledge of national health legislation and experience with the ISP.

What does Abbott offer in terms of career development and work environment?

Abbott provides professional development with an international company to grow your dream career, is recognized as a best place to work in dozens of countries, and supports being yourself while living a full life.

What is the salary or compensation for this role?

This information is not specified in the job description.

What experience makes a strong candidate for this position?

Strong candidates will have a relevant university degree and hands-on experience with national health legislation and the ISP, as these are explicitly required.

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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