**Company Description****Major Responsibilities**:- 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 updateson progress and/or issues that may impact the global program; - Leads ARPTs to ensure that Regulatory programs can be effectively carried forward across all countries within the Area; - Interacts with stakeholders across functions to ensure that Regulatory strategies are aligned with enterprise business objectives; - Represents Area on process improvement initiatives of low- to medium-complexity; is able to represents the needs of Area and Affiliates as appropriate; - Leads team meetings effectively; appropriately escalatesand 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.**Qualifications** Required Education**:- Bachelor's degree in pharmacy, biology, chemistry, pharmacology etc.**Preferred Education**:- Advanced degree(s); - English and Spanish are required. Portuguese fluency is preferred.**Required Experience**:- 5+ years' related experience; - Proven leadership skills and presence; - Experience interfacingwith government and health authorities; - Experience working in a complex and matrix environment; - Strong verbal and written communication skills; - Ability to work with cross-functional teams; - Ability to interact with different levels of stakeholders; - Strong attention to detail and problem-solving skills; - Effective use of negotiation skills to resolve issues in cross-functional teams to ensure completion of assigned tasks; - Keen awareness to cultural nuances; proven ability to work in a global environment; - Ability to successfully interact with multi-divisional and multi-functional teams from across the globe.**Additional Information**US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: