Regulatory Affairs Specialist: Submissions & Compliance

AbbVie; Cundinamarca; Presencial; COP 226.552.000 - 356.010.000; Jornada completa

Descripción de la vacante

AbbVie is seeking a Regulatory Affairs professional to support execution of regulatory activities for the assigned portfolio, ensuring compliance with local regulations and company policies. You will assist with submissions, lifecycle management, and interactions with health authorities.

The role emphasizes collaboration with cross‑functional teams, maintaining documentation, and contributing to risk assessment and timely responses to inquiries, while growing technical knowledge under the

Formación

• University degree in Pharmacy or related field with equivalent experience.
• Intermediate English proficiency (B1–B2) for reading regulatory documents and routine communications.

Responsabilidades

• Support submissions for new marketing authorizations, variations, renewals, and lifecycle activities.
• Maintain regulatory documentation and licenses in compliance with local requirements.
• Collaborate with local authorities and escalates complex questions to senior team members.
• Assist in preparing responses to health authority questions and follow ups.
• Track post‑approval commitments and ensure timely completion.
• Support regulatory documentation for new product applications and launches.
• Review promotional materials for regulatory compliance.
• Support labeling and packaging implementation per approved information.
• Maintain regulatory databases and submission documentation.
• Provide regulatory support to cross‑functional teams (Medical, Commercial, Quality, etc.).
• Monitor regulatory updates and assess potential impact.
• Organize priorities and communicate status to stakeholders.

Conocimientos

Regulatory Affairs

Cross-functional collaboration

Written & verbal communication

Attention to detail

Regulatory databases knowledge

Educación

Pharmacy degree

Health sciences degree considered

Herramientas

Regulatory databases

Electronic document management systems

Descripción del empleo

AbbVie is seeking a Regulatory Affairs professional to support execution of regulatory activities for the assigned portfolio, ensuring compliance with local regulations and company policies. You will assist with submissions, lifecycle management, and interactions with health authorities.

The role emphasizes collaboration with cross‑functional teams, maintaining documentation, and contributing to risk assessment and timely responses to inquiries, while growing technical knowledge under the