Job Description The mission of the Botox & AA Regulatory Affairs Coordinator 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 activities Devise 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 activities Management 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 Support Participate 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 Intelligence Keep the affiliate and region informed on new regulations with impact on the business Qualifications Pharmacist Minimum 5 years' experience in Regulatory Affairs Knowledge of applicable regulations, both for Argentina and Chile English: intermediate level as minimum Trained in applicable local and international policies and procedures Good 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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