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 DescriptionKey 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.
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
Skills Required
- Bachelor's degree in Pharmacy, Biomedicine, Chemistry, Biology, or related life science field
- Minimum 4-5 years' experience in Regulatory Affairs within pharmaceutical or biotechnology industry
- Hands-on experience with ANVISA submissions and post-approval change management (medicines and medical devices)
- Experience with biological products
- Experience supporting Medical Advisors and cross-functional medical/regulatory interactions
- 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 Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.
-
Retirement Support — 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
-
Parental & Family Support — Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
-
Healthcare Strength — Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.
AbbVie Insights
What We Do
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.
.jpg)
