Regulatory Affairs Senior Director - LATAM - Medical Devices
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Johnson & Johnson MEDICAL DEVICE is one of three successful divisions of the world's leading Johnson & Johnson family of companies. We are making an important contribution to the successful treatment of a wide range of common and chronic diseases with innovative - often pioneering - medical technologies and products.
Responsible for leading a regional Regulatory Affairs team to develop and execute the regulatory strategy and action plan to support and enhance business growth and results across the Medical Device business units in the region.
• Define and develop a clear and influential future vision and strategy for the regional regulatory affairs, based on current and anticipated regulatory requirements, by aligning with global regulatory strategy and regional business strategy,
• Establish short term and long-term strategic goals and implementation plans to achieve objectives and business results. Advise on regional, country and / or cultural differences and potential impact on business.
• Lead the regional team in proactively shaping external regulatory environment and active engagement with the regulators to drive and influence the regulatory harmonization in the region
• Lead the regional regulatory team to deliver and accelerate product approvals by developing and executing regulatory strategies that are aligned with business objectives
• Maintain market access by providing regulatory inputs to product lifecycle management and evaluation regulatory impact on products.
• Ensure product compliance with each authority’s regulatory requirements. Keep monitoring the regulation changes to make timely impact assessment, communicate the impact with the business partners to drive relevant actions.
• Responsible for the detailed RA budget planning and control, lead the team to manage the project and regulatory activities within timeline and budget requirement. Determine and communicate the financial implications of regulatory activities on business results.
• Support key acquisitions and divestitures, provide comprehensive regulatory assessment and prepare for the expertise and resources to support the execution.
• Establish close and collaborative partnerships with business and functional stakeholders in the region.
• Partner with Supply Chain in managing related projects to drive change management, labeling, cost improvement and transformation relation projects, with providing timely and comprehensive regulatory assessment to optimize market access maintenance.
• Create a diverse, vibrant and capable regulatory workforce and promote the importance of recognizing and embracing culture differences. Build a sustainable talent pipeline for the future through active recruitment, retention, and development strategy.
• Support and drive long-run regulatory sustainable model, including improvement and development of regulatory process excellence, effective tools and system
• Active member of the global regulatory affairs leadership team. Advise on global strategy, regional impact and priorities and partner with business sector regulatory affairs and functional leaders to executive the global regulatory affairs strategy.
• Bachelor's degree and above. Advanced degrees and education in medicine, engineering, science or law highly preferred
• Very solid experience in a regulated industry, with experience in management positions including managing people. Medical Device experience preferred but not required.
• Senior leadership experience is required, especially interacting with senior leaders and influencing strategy and decision making at senior levels
• Demonstrated track record of formulating regional regulatory strategies that align with business deliverables is required
• Experiences and leadership in working with external industry groups and International organizations is a plus;
• Strong English language (spoken and written) capability; other languages of regional countries are welcomed.
• Live the credo in a way that creates a trusting, collaboratively and ethical work environment
• Strong leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Grow
• Connect by cultivating external relationships with regulators and internally collaboration with the Franchise, Policy and Central regulatory organizations and with the other functions
• Shape by anticipating and influencing regulatory changes and maximize patient access to innovative Franchise technologies
• Lead by acquiring and developing a diverse team of talented regulatory professionals and transparently communicating in a constructive manner
• Deliver by mobilizing and inspiration an accountable team to deliver the results for on-time registrations with a global and enterprise-wide mindset and balance with strategic and short-term goals
Brazil-São Paulo-São Paulo-
Latin America-Mexico-Estado de México, Latin America-Colombia-Distrito Capital de Bogotá-Bogotá
J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. (7600)