Regulatory Affairs Specialist

Mission 

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 AbbVie policies. The Co-technical director is AbbVie’s representative before the regulatory authorities in Uruguay as well as the link with the representative in Paraguay.

Main responsibilities

1. Regulatory Affairs activities

• Devise regulatory strategies, aligned within the Brand Team, for successfully registering oncology and

specialty products in Uruguay and Paraguay.

• Be AbbVie’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.

2. Business Support

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

regulatory intelligence

3. Regulatory Intelligence

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