Regulatory Affairs Coordinator (Suba)

Organizational Relationships

Direct Report to Regulatory Affairs Head / Sr. Manager / Manager (as applicable)

• Works closely with local PCO BU teams in country and internal stakeholders
• Works closely with above country support as GRA-I LatAm Regional Hub, Hub Regulatory Strategists, GRA Product Strategists, Submissions Management, GCMC, Medical managers and other relevant support areas involved in product registration and product lifecycle management processes

Position Purpose

• Participate in the planning of Regulatory strategies for products submissions and lifecycle including also the APIs related to products under responsibility
• Coordinate and execute activities related to 1) Dossier planning and submission -paper and/or electronic for initial registration and maintenance of Drug products including product renewals for the assigned portfolio(s), 2) Clinical Trial Applications, for country acceptability in terms o...