Company Description
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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.
Job Description
The mission of the Botox & AA Regulatory Affairs Specialist is to be responsible for the regulatory activities related to Botox and aesthetic products in Argentina and Chile, aligned to business needs, to assure compliance with local regulations and with AbbVie policies.
Regulatory Affairs activitiesDevise regulatory strategies, aligned within the Brand Team, for successfully registering Botox, other toxins and medical products in Argentina and Chile.Participation in local trade association as deputy for the technical director, to advocate on regulations in line with the company's interests and to propose changes in the regulatory environment to safeguard AbbVie's assets.Execution and follow up of activities related to products life cycle (renewals, variations, withdrawals, launches, etc.)Management of artworks related activitiesManagement of regulatory audits (preparation, execution, resolution)Work with area teams in special projects, representing Chile or Region South.Revision of promotional materials for the Aesthetic Business.Business SupportParticipate in Brand Teams, as an active member, proposing and giving regulatory insights and providing regulatory intelligence and strategies to accelerate the entrance of required products.Support business initiatives and the Ethics and Compliance program, efficiently communicating the regulatory perspective.Review the documents to open accounts for the Aesthetic business both in Argentina and in Chile.Regulatory IntelligenceKeep the affiliate and region informed on new regulations with impact on the business
Qualifications
PharmacistMinimum 5 years' experience in Regulatory AffairsKnowledge of applicable regulations, both for Argentina and ChileEnglish: intermediate level as minimumTrained in applicable local and international policies and proceduresGood communications skills
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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