AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

• Autonomously execute regulatory activities of minor, moderate and major complexity, including new product registrations and moderate/major post‑registration changes and medical device products.
• Propose pragmatic regulatory solutions for complex situations, assess cross‑functional impacts, and align recommendations with company strategy.
• Follow and help operationalize the regulatory strategy established with the Regulatory Affairs Leadership.
• Actively participate in local business and regulatory strategy meetings and represent the company in meetings with class entities when required.
• Serve as a local expert/focal point on complex regulatory issues, monitoring legislation, assessing regulatory impact, and developing implementation plans for new legislation or requirements.
• Prepare, define and revise all registration and post‑registration documentation in accordance with Brazilian law and company procedures.
• Prepare legal text and review final package insert (leaflet) wording and labeling/artwork for legal consistency with registration and legislation.
• Request and monitor inspections of AbbVie sites and partners abroad and follow GMP inspection processes until closure.
• Ensure accurate updates to AbbVie regulatory systems and spreadsheets (registrations, package inserts, labeling, legal documents, cGMP documentation) and maintain control of the registration/package update workflow in regulatory systems.
• Review and approve promotional materials in accordance with internal policies, codes of conduct and applicable legislation.
• Provide regulatory guidance to internal client areas and stakeholders and mentor junior regulatory analysts to accelerate issue resolution.
• Comply with company Codes of Business Conduct and Ethics and all relevant policies and procedures.

• Bachelor’s degree in Pharmacy, Biomedicine, Chemistry, Biology or related life‑science field.
• Experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with hands‑on experience in ANVISA submissions and post‑approval change management (medicines and medical devices).
• Demonstrated experience with labeling/package insert text, regulatory dossier preparation, and interactions with regulatory authorities.
• Knowledge of GMP inspection processes with manufacturing partners.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities autonomously.
• Excellent verbal and written communication skills.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html