Key Responsibilities

• Autonomously execute regulatory activities of minor, moderate and major complexity, including new product registrations and moderate/major post-registration changes, with a focus on Allergan Aesthetics products, including 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.