About this role
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. Bachelor’s degree in Pharmacy, Biomedicine, Chemistry, Biology, or related life science field;Minimum 4–5 years’ 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);Experience with biological products is required;Experience supporting Medical Advisors and cross-functional medical/regulatory interactions is required;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.
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