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Company Description
Job Description 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
- 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 general 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 expl

Postúlate en Kit Empleo: kitempleo.cl/empleo/1dack3

📌 Immunology, Botox (Santiago)
🏢 Abbvie
📍 Santiago