Immunology, Botox & AA Regulatory Affairs Specialist

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 at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Position Mission

Ensure compliance of AbbVie´s requirements and local regulation to Regulatory Affairs.

Give support to Regulatory Affairs activities.

Work to ensure the achievement and maintenance of health records and other required authorizations for products marketing activities of the affiliate complying with local and headquarters laws.

Achieve and maintain the leadership attributes of AbbVie within the framework of compliance as part of a high standard performance. 

Core Responsabilities

1. Regulatory Affairs activities

• Collaborate in preparation to records, renewal and modification of record according to local regulation.
• Collaborate in fulfillment of current legislation on medicines, for products that are planned to be marketed by AbbVie. Communicate timely and in advance to the Area.
• Assist the Business Divisions with necessary technical and regulatory information on government tenders and support in the process of launching new products
• Keep current legal documents updated for tender process.
• Collaborate in the authorization submission records to meet the established deadlines for AbbVie, ensuring compliance to avoid risk itself. (Example: safety modifications, quality specification, legal changes, among others).
• Prepare CCDS change to review medical area, submit MoH and implementation these changes in local and source leaflet.
• Follow up authorization requests.
• Complete the training of global procedure and local procedure if applicable on time to avoid risks of noncompliance of the company and ensure the implementation of such procedures in the corresponding activities.
• Report and notify internal "stakeholders" about the regulatory activities through the AbbVie systems.
• Keep updated local, area and global database required in AbbVie (COSMOS, AMP, AMS, GSSC, etc).
• Prepare and maintain database to tender process (Example: CPP, GMP, CoAs, Pharmacovigilance Certificate issue by MoH, letter that explain to reference product and without recall or withdraw of market, etc).
• Active participation in Immunology (BT), review strategies, updated new records, new indication, etc.
• Active participation in Area Regulatory Meeting, in order to align and plan the next submissions.
• Prepare and implement local guides/instructions when required (When it does not cover for global process).
• Support to QA in activities of third parties that provide services related to AbbVie Chile Products, ensuring compliance with AbbVie´s policies and current regulations.
• Develop and maintain updated packaging materials to be used locally in the overlabeling process.
• Participate in the development and approval of packaging materials implemented by the manufacturing sites.
• Review and Approve master conditioning order for the correct overlabeling of products by the TPM.

• Pharmacist
• Minimum 4 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

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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