Regulatory Affairs Specialist - Submissions & Compliance

BioSpace; Cundinamarca; On-site; COP 50,000,000 - 70,000,000; Full time

Job summary

AbbVie is seeking a Regulatory Affairs Associate to support regulatory activities for products in the assigned portfolio, ensuring compliance with local regulations and company policies.

You will help prepare submissions for new marketing authorizations, variations, and lifecycle activities, maintain licenses, respond to health authority questions, and coordinate with cross-functional teams to mitigate risks and meet timelines.

Qualifications

• University degree in Pharmacy or related health sciences.
• English proficiency at B1-B2; able to read regulatory documents.
• Typical 2-3 years of experience in Regulatory Affairs in pharma.
• Experience with drug product registrations, lifecycle management, variations or regulatory maintenance.
• Knowledge of local regulatory requirements and submission processes.
• Attention to detail and ability to work with more experienced colleagues.
• Strong written and verbal communication; ability to collaborate in cross-functional teams.

Responsibilities

• Support execution of regulatory activities for products in the assigned portfolio.
• Prepare, submit, follow-up, and maintain regulatory applications including registrations and lifecycle activities.
• Assist with complex regulatory matters in collaboration with senior colleagues.
• Prepare submissions for new marketing authorizations, variations, renewals, and other lifecycle activities.
• Maintain product licenses and regulatory documentation in compliance with requirements.
• Respond to health authority questions; provide timely updates and escalation when needed.
• Support post-approval commitments and regulatory documentation for new applications and launches.
• Review promotional materials for regulatory compliance and ensure alignment with information.
• Support labeling, prescribing information, and packaging updates as required.

Skills

Cross-functional collaboration

Excellent written and verbal skills

Attention to detail

English proficiency (B1-B2)

Education

University degree in Pharmacy or related health sciences

Tools

Regulatory databases

Electronic document management

Job description

AbbVie is seeking a Regulatory Affairs Associate to support regulatory activities for products in the assigned portfolio, ensuring compliance with local regulations and company policies.

You will help prepare submissions for new marketing authorizations, variations, and lifecycle activities, maintain licenses, respond to health authority questions, and coordinate with cross-functional teams to mitigate risks and meet timelines.