Regulatory Affairs Specialist

Company Description

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

The mission of the Oncology and Specialty Regulatory Affairs Specialist is to be responsible for the regulatory activities related to oncology and specialty products in Paraguay and Uruguay, aligned to business needs, to assure compliance with local regulations and with Abb Vie policies. The Co-technical director is Abb Vie’s representative before the regulatory authorities in Uruguay as well as the link with the representative in Paraguay.

• Devise regulatory strategies, aligned within the Brand Team, for successfully registering oncology and specialty products in Uruguay and Paraguay.
• Be Abb Vie’s representative before the MSP (local HA) as Co-Technical Director. The technical director and his deputy are legally liable in solidarity with the company, using her or his signature to back up not only the filings but also the importation and exportation of products and the release of such products to the internal market.
• Execution and follow up of activities related to products life cycle (renewals, variations, withdrawals, launches, etc.).
• Lead the interaction with distributor in Paraguay (RA personnel) to assure successful and on time registrations and business continuity, training the regulatory affairs personnel of the distributor and preparing the regulatory documents for submission.
• Management of artworks related activities.
• Management of regulatory audits (preparation, execution, resolution).
• Work with area teams in special projects, representing Uruguay and Paraguay.

• Participate in Brand Teams, as an active member, proposing and giving regulatory insights and providing regulatory intelligence.

• Keep the affiliate and region informed of new regulations with impact on the business.

• Bachelors as a Pharmacist or correlated areas
• Minimum 5 years’ experience in Regulatory Affairs
• Knowledge of applicable regulations, both for Uruguay and Paraguay
• Negotiation skills
• English: working level as minimum
• Trained in applicable local and international policies and procedures
• Team management skills
• Good communications skills

Abb Vie 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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