Regulatory Affairs Specialist: Submissions & Compliance

Abbvie; Girardot; On-site; COP 70,000,000 - 90,000,000; Full time

Job summary

AbbVie in Bogota, Colombia is seeking a Regulatory Affairs Specialist to support regulatory activities for products within the assigned portfolio, ensuring compliance with local regulations, approved plans, and company policies. You will prepare submissions, manage lifecycle activities, and collaborate with senior colleagues to maintain product licenses and documentation.

You will work on interactions with health authorities, track post-approval commitments, and help align labeling and packaging

Qualifications

• University degree in Pharmacy or related careers with equivalent experience.
• Intermediate English proficiency, typically equivalent to B1-B2.
• Typically 2-3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Practical exposure to drug product registrations, lifecycle management activities, variations, renewals, or regulatory maintenance processes.
• Working knowledge of local regulatory requirements and submission processes.
• Ability to prepare and review regulatory documentation with attention to detail and guidance from more experienced colleagues.
• Good written and verbal communication skills, organization, follow-up, and ability to manage several assigned activities.

Responsibilities

• Prepare and support submissions for new marketing authorizations, variations, renewals, notifications, and other lifecycle management activities for the assigned portfolio.
• Maintain product licenses and regulatory documentation in accordance with local requirements, approved product information, supply needs, and internal procedures.
• Perform assigned activities in alignment with applicable standard operating procedures and regulatory requirements.
• Support routine interactions and follow-up with local regulatory authorities. Escalate complex questions or issues to senior team members or the Regulatory Affairs Manager.
• Assist in preparing accurate and timely responses to health authority questions and requests.
• Support completion and tracking of post-approval commitments within required timelines.
• Contribute to the prepatarion of regulatory documentation and provide operational support for new product applications and launches.
• Review promotional and non-promotional materials for regulatory compliance, following regulations and established review processes and guidance.
• Support labeling, prescribing information, and packaging component implementation to maintain alignment with approved information and local regulations.
• Maintain regulatory databases, trackers, records, and submission documentation accurately and on time.
• Provide regulatory support to cross-functional activities involving Medical, Commercial, Market Access, Quality, Supply Chain, and other relevant functions.
• Monitor regulatory updates, communicate relevant changes to the team, and support assessment of their potential impact.
• Organize priorities, identify risks or delays, and provide timely status updates to the manager and relevant stakeholders

Skills

Regulatory affairs

English proficiency

Cross-functional collaboration

Documentation management

Education

Pharmacy degree

Tools

Regulatory databases

Job description

AbbVie in Bogota, Colombia is seeking a Regulatory Affairs Specialist to support regulatory activities for products within the assigned portfolio, ensuring compliance with local regulations, approved plans, and company policies. You will prepare submissions, manage lifecycle activities, and collaborate with senior colleagues to maintain product licenses and documentation.

You will work on interactions with health authorities, track post-approval commitments, and help align labeling and packaging