Work Flexibility: HybridPrincipal RA SpecialistScope of the roleGlobalPosition summaryPossesses and applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.Key areas of responsibilityAssesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategyParticipates in advocacy activities of a more advanced strategic natureDevelops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategiesProvides guidance to integrate regulatory considerations into global product entry and exit strategyIdentifies regulatory pathways for initial product designs and provides input to internal stakeholdersAnalyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomesAssesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstaclesCritically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulationsProvides in-depth understanding and ability to incorporate regulatory strategies to expedite development 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 lifecycleEstablishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distributionIdentifies the need for and manages the development and execution of new regulatory procedures and standard operating proceduresDevelops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide complianceProvides strategic input and technical guidance on global regulatory requirements to product development termsEvaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutionsEvaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissionsReviews and assesses proposals to regulatory authorities on regulatory paths and clinical plansMonitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phasesProvides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationshipsProvides regulatory guidance on strategy for proposed product claims/labelingEnsures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claimsManages electronic (eCTD) and paper registration developmentEnsures policies and procedures are in place for appropriate internal review and approval of regulatory submissionsLeads key negotiations and interactions with regulatory authorities during all stages of the development and review processPrepares cross-functional teams for interactions with regulatory authorities including panel/advisory committeesEducation / work experienceBS in Engineering, Science, or related Advanced degree desired or MS in Regulatory ScienceTypically, a minimum of 9 relevant RA years' experienceRAC(s) desiredKnowledge / competenciesArticulates the organization's strategic vision in a manner that enables others to execute plans, tactics, and actionsContinually identifies and informs appropriate individuals on emerging trends, opportunities, and threatsLeverages a well-grounded knowledge of applicable laws, regulations and policies to develop and execute plans and programsEnsures strategies, analyses, and plans consider anticipated long-range requirements and are not just based on the current situationMakes informed decisions based on business frameworks and tools and give consideration to risks tradeoffs, timing, and available resourcesProactively manages and monitors progress against desired outcomes including working with others to establish and adjust contingency plans, revising and adapting processes, communicating success and learning from mistakesDemonstrates the ability to build agreement and acceptance through an ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructivelyContinuously develops staff by making accurate assessments of individual's capabilities and performance, and providing feedback, coaching, guidance, and mentoringDemonstrates sensitivity and understanding of cultural considerations when dealing with othersEmbraces scrutiny and accepts feedback as opportunity to learn and improveWillingly accepts challenging assignments and new career opportunities that stretch and build capabilitiesTravel Percentage: 10%
