Work Flexibility: Hybrid Principal RA Specialist Scope of the role Global Position summary Possesses and applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation,processesand procedures.
Key areas of responsibility Assesses links between global,societaland economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy Participates in advocacy activities of a more advanced strategic nature Develops and updates global,regionaland multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies Provides guidance to integrate regulatory considerations into global product entry andexit strategy Identifiesregulatory pathways forinitialproduct designs and provides input to internal stakeholders Analyzesthe adequacy of proposed regulatory pathways and strategy forinitialproduct designs and recommends changes or refinements based oninitialregulatory outcomes Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement,purchasinggroups, etc.) and develops solutions to addressanticipatedobstacles Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations Provides in-depth understanding and ability to incorporate regulatory strategies toexpeditedevelopment for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy) Negotiates with regulatory authorities on complex issues throughout the product lifecycle Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution Identifiesthe need for and manages the development and execution of new regulatory procedures and standard operating procedures Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Provides strategic input and technical guidance on global regulatory requirements to product development terms Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans Monitors implementation of regulatory strategiesrelativeto product and clinical safety issuesidentifiedduring clinical phases Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships Providesregulatory guidance on strategy for proposed product claims/labeling Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims Manages electronic (eCTD) and paper registration development Ensures policies and procedures are in place forappropriate internalreview and approval of regulatory submissions Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees Education / work experience BS in Engineering, Science, or related Advanced degree desired or MS in Regulatory Science Typically,a minimum of 9relevant RAyears' experience RAC(s) desired Knowledge / competencies Articulates the organization's strategic vision in a manner that enables others to execute plans, tactics, and actions Continuallyidentifiesand informsappropriate individualson emerging trends, opportunities, and threats Leverages a well-grounded knowledge of applicable laws,regulationsand policies to develop and execute plans and programs Ensures strategies, analyses, and plans consideranticipatedlong-range requirements and are not just based on the current situation Makes informed decisions based on business frameworks and tools andgive consideration toriskstradeoffs, timing, and available resources Proactively manages and monitors progress against desired outcomes including working with others toestablishand adjust contingency plans,revisingand adapting processes, communicating success and learning from mistakes Demonstrates the ability to build agreement and acceptance through an ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructively Continuously develops staff by makingaccurateassessments of individual's capabilities and performance, and providing feedback, coaching, guidance, and mentoring Demonstrates sensitivity and understanding of cultural considerations when dealing with others Embraces scrutiny and accepts feedback as opportunity to learn and improve Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities Travel Percentage: 10%