Job Title:
Manager, Regulatory Affairs

Req #:
4661BR

Job Description:
Responsible for Regulatory activities in Latin America.

Job Duties:
Communicate with the Commercial team, Global Strategy, and local country managers. Work with the Global Regulatory Affairs group to develop work schedules to best meet regional and global demands. Act as the liaison with relevant internal departments and licensing authorities to drive projects to successful conclusion and to meet company-agreed goals. Work closely with B&L affiliates (Germany, France, UK, Canada) to coordinate projects. Provide timely resolution to issues raised by national health authorities. Respond to general regulatory queries. Ensure key personnel at B&L organization are kept informed of developments in a timely manner.

Qualifications


Education:
BS/BA degree in technical or scientific discipline required. Advanced degree or additional professional training preferred. Minimum 7 years experience in Regulatory Affairs (Pharma). Experience: Experience in preparing medical device submissions and food supplements a plus. Project management experience or similar experience within R&D preferred. Must have excellent communication, organization and writing skills. Strong influencing and negotiation skills. Commercial knowledge and understanding of business needs. Computer literate (MS) and internet use.

Special Skills:
Must be familiar with existing legislation and keep up-to-date on development and trends affecting product registration worldwide. Specialized Training: Must be fluent in Spanish language.

Work Location FL - Tampa Relocation Available Yes

Status Full-Time