AstraZeneca
DirectorRegulatoryPolicy&IntelligenceLATAM
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“Director Regulatory Policy & Intelligence LATAM at AstraZeneca. Skills: Regulatory Policy, LATAM, International Regulatory Affairs, Stakeholder Management. Drive regulatory policy development and advocacy for LATAM. Co-develop policy positions”
What You'll Achieve.
Enable impactful external engagement on AZ’s regulatory science priorities; Influence proposed rules and regulations affecting AZ and the industry; Lead implementation of changes to international strategies and processes resulting from new legislation or guidance; Coordinate AZ’s responses to key regulatory policy topics at LATAM, International, and Global levels; Assess legislative and environmental changes for their impact on product strategy; Communicate relevant insights to International Regulatory Affairs (inRA) Strategy groups for onward communication to Global Project Teams; Support with the oversight and management of international policy and intelligence scorecard KPIs, and its metrics for performance internally and externally
Industry & Context.
Problem solving skills; The ability to think strategically and critically and evaluate risks to regulatory activities
What They're Looking For.
Must Have
10+ years in global regulatory affairs, international regions (Asia, Latin America and Middle East & Africa), Demonstrated expertise in Regulatory policy related matters, Health Authority or Industry experience, Working knowledge of AZ focused disease areas, new therapeutic modalities, CMC & quality, cross-area topics, Thorough understanding and application of the Drug Development and associated regulatory processes globally and internationally, Working experience in developing and executing new product strategies for global and international regions across different therapeutic areas, A collaborative, entrepreneurial mindset, comfortable with ambiguity, adept at building from the ground up, Demonstrated proficiencies in critical thinking, critical influencing, innovation, initiative, leadership, excellent oral and written communication skills, The ability to think strategically and critically, evaluate risks to regulatory activities, Collaborative, building consensus with peers and leadership, ability to influence upwards, oral and written communication skills, Experience in knowledge management, digital information management
Nice to Have
Prior experience with phase 3 design including end of phase 2 health authority interactions, Contribution to a regulatory approval including leading response team and labelling negotiations, Experience working in Health Authority, Focus on delivery and results, Experience in new modalities ie antibody conjugates, cell and gene therapy, radiotherapeutics, Experience of participating in key industry groups and policy for especially within LATAM, Excellent strategic influencing and negotiation, Experienced Regulatory Professional with degree in scientific discipline, typically pharmacy and biological science, Experience or aptitude in using AI/Gen AI within regulatory space
What You'll Do.
Drive regulatory policy development and advocacy for LATAM
Co-develop policy positions
Coordinate stakeholder interactions
Implement policies regionally
Enable impactful external engagement
Provide strategic view based on deep knowledge
Maintain and build health authority relationships
Influence proposed rules and regulations
Lead implementation of changes to international strategies
Coordinate AZ’s responses to key regulatory policy topics
Assess legislative and environmental changes
Communicate relevant insights to International Regulatory Affairs
Lead or manage regulatory policy priority topics
Provide key regulatory procedural/ environmental advice
Support preparation of regulatory policy documents
Support oversight and management of international policy and intelligence scorecard KPIs
Support development for International Regulatory Policy Training Capability Framework
Establish the international CMC-RA Policy Framework
Represents AZ International Regulatory Affairs on external committees
Represent AZ in external benchmarking
How You'll Work.
Team & Collaboration
Partnering closely with the Senior Area Regulatory Director–LATAM; Partnering closely with the International Policy & Intelligence Lead; Partnering closely with regional Marketing Companies; Partnering closely with global/regional functions; Collaborative and able to be building consensus with peers and leadership
Communication Scope
excellent oral and written communication skills; oral and written communication skills
Process & Methodology
Lead implementation of changes to international strategies and processes
Full Job Description
**Director Regulatory Policy & Intelligence - AstraZeneca** The International Regulatory Policy Director for LATAM is a strategic leadership role within the International Regulatory Policy & Intelligence team, partnering closely with the Senior Area Regulatory Director–LATAM, the International Policy & Intelligence Lead, regional Marketing Companies, and global/regional functions. The Director drives regulatory policy development and advocacy for LATAM and selected international topics, co-develops policy positions, coordinates stakeholder interactions, and implements policies regionally to enable impactful external engagement on AZ’s regulatory science priorities, disease areas of interest, new therapeutic modalities, CMC & quality, and cross-functional topics. The role provides a broad strategic view based on deep knowledge of LATAM and international regulatory environments, maintains and builds health authority relationships, influences proposed rules and regulations affecting AZ and the industry, leads implementation of changes to international strategies and processes resulting from new legislation or guidance, and coordinates AZ’s responses to key regulatory policy topics at LATAM, International, and Global levels. The Director also assesses legislative and environmental changes for their impact on product strategy and communicates relevant insights to International Regulatory Affairs (inRA) Strategy groups for onward communication to Global Project Teams. Would you like an even shorter version suitable for a posting headline or social media? **Typical Accountabilities** * Lead or manage regulatory policy priority topics as coordinated by the Global Regulatory Policy Team /International Policy and Intelligence lead * Provide key regulatory procedural/ environmental advice on assigned topics to key customers/stakeholders within international and Global, including the Regulatory TAs, Commercial, MC regulatory, R&D, Operations and CMO functions. * Support prepara
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