Dr. Reddy's Laboratories

Global generic medicines and APIs exporter

Regulatory Affairs Specialist

Regulatory & Quality (Life Sciences)Posted on Nov 12

Full-timeBogotá, Bogota, ColombiaNo salary listedIn-person

About the Job

Requirements

A professional qualification in Pharmaceutical Chemistry is required.
At least 5 years of experience in Regulatory Affairs is required, focused on human-use medicines.
Fluent English is required.

Responsibilities

Review and prepare dossiers comprehensively from start to finish, rather than only compiling documents.
Apply practical knowledge of the pharmacological/clinical, technical/quality, and legal components of a health registration.
Handle new health registrations, amendments, and maintenance activities.
Respond directly to complex INVIMA notices and requests.
Interact directly with INVIMA and exercise appropriate judgment in communications with the health authority.
Identify documentary gaps, assess regulatory risks, and develop viable response strategies.

Desired Qualifications

Experience with innovative products is desired, preferably including exposure to biologics and/or biosimilars.
Knowledge of bioequivalence is desired, especially for candidates with limited experience in biologics or biosimilars.

Descripción del empleo

Tu reto esta enfocado a:

Revisión y preparación integral de dossiers de principio a fin, no solamente compilación documental.
Conocimiento práctico de los componentes farmacológico/clínico, técnico/calidad y legal de un registro sanitario.
Experiencia con nuevos registros sanitarios, además de modificaciones y actividades de mantenimiento.
Experiencia directa respondiendo autos y requerimientos complejos de INVIMA.
Interacción directa con INVIMA y criterio adecuado para gestionar comunicaciones con la autoridad sanitaria.
Capacidad para identificar brechas documentales, evaluar riesgos regulatorios y construir estrategias de respuesta viables.
Experiencia con productos innovadores y, preferiblemente, exposición a biológicos y/o biosimilares.
Conocimiento de bioequivalencia, especialmente cuando la experiencia con biológicos o biosimilares sea limitada.

Requisitos

Estamos buscando talento con profesión en Químico Farmacéutico, con experiencia de 5 años o más en Asuntos Regulatorios. Con esperiencia en Medicamentos de uso humano.

Ingles fluido

Información adicional

About the Company

Dr. Reddy's Laboratories

Global generic medicines and APIs exporter

Dr. Reddy's Laboratories focuses on affordable generic medicines and pharmaceutical ingredients. Its products include generic drugs and active pharmaceutical ingredients (APIs) produced in-house and distributed worldwide. The company grew from a Hyderabad-based startup in 1984, becoming the first Indian firm to export APIs to Europe in 1986 and to enter the U.S. market in the early 1990s, culminating in a 2001 NYSE listing that underscored its global standards. Today, the group operates in over 150 countries, supported by ongoing research and development to create new and improved medications. The core goal is to improve global health by providing high-quality, affordable healthcare solutions at scale.

Company size: 10,001+
Company stage: IPO
Headquarters: Hyderabad, India
Founded: 1984

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