X-194 - Regulatory Affairs Specialist
- Buenos Aires
- Permanente
- Tiempo completo
- 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 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 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.**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 interfacing with 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:
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