Immunology, Botox & AA Regulatory Affairs Specialist

Position Mission

Ensure compliance of AbbVies 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 AbbVies 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.

Qualifications :

• 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

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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

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