Senior Regulatory Affairs Analyst

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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.

Qualifications

• 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.

Additional Information

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