Your Role:

The Regulatory Affairs Manager BRAZIL  develops and executes regulatory strategies in alignment with Global and Affiliate Regulatory colleagues as appropriate. S/he represents Brazil  on the Global Regulatory Product Teams (GRPTs) and leads Area Regulatory Product Teams (ARPTs) to identify and compile the information necessary to register and properly maintain regulatory applications to Health Authorities across the Area. This role also interfaces with partner functions (e.g., Commercial, Market Access, Quality Assurance) to ensure Regulatory strategies are aligned with business objectives.

Key responsabilities:

• Provides strategic direction to support the development of compliant and competitive Regulatory programs.
• Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to drive complete and timely information to Health Authorities.
• Effectively incorporates country-specific regulatory requirements, guidance, and other relevant regulatory intelligence into Regulatory submissions across the Area.
• Interacts with GRPTs and other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; provides timely updates on progress and/or issues that may impact the global program.
• Leads ARPTs to ensure that Regulatory programs can be effectively carried forward across all Brazil.
• Interacts with stakeholders across functions to ensure that Regulatory strategies are aligned with enterprise business objectives.
• Represents Brazil on process improvement initiatives of low- to medium-complexity; is able to represents the needs of Brazil.
• Leads team meetings effectively; appropriately escalates and drives issues to resolution; demonstrates good negotiation skills, effective group facilitation skills, and ability to drive consensus among team members.
• Develops effective working relationships with project team members; prepares and delivers clear, relevant, and influential deliverables for a variety of audiences.

Incorporates diverse, cross-functional, and global perspectives into strategies & tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization.