Work Flexibility: Hybrid

Regulatory Affairs Manager

Key Areas of Responsibility:

Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy           Develops 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 claimsEnsures 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 committeesManage day-to-day regulatory processes to ensure issues are appropriately evaluatedEstablish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvementCommunicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are metServe as Subject Matter Expert for regulatory processesProvide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectationsEstablish standard process to ensure appropriate resolution and management of the responsible task ownerChair meetings required to drive closure of regulatory issuesManage and provide updates for regulatory metrics. Implement appropriate enhancementsRepresent regulatory processes during internal and external auditsDefine targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targetsRecruit, select, and on-board top talentDevelop talent within team to increase performance. Actively address performance issues on teamMaintain a high level of team engagementParticipates in advocacy activities of a more advanced technical and/or tactical or strategic natureEstablish annual budgets and quarterly forecastsMake necessary changes with appropriate management involvement

Education / Work Experience:

BS in a science, engineering or related Advanced degree preferredMinimum of 8 years experienceMaster's Degree or equivalent preferredRAC DesiredPeople Management experience required

Knowledge / competencies

Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirementsDemonstrate technical knowledge of medical device product linesDemonstrated written, verbal, listening, communication, and team-building skillsDemonstrated ability to collaborate effectively with and lead cross-functional teamsDemonstrated ability to effectively prioritize and manage multiple project workloadsDemonstrated experience with trending and analysis reportingDemonstrated leadership skillsDemonstrated process improvement and management skillsExperience with recruiting, people developmentInfluence across the organization

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Travel Percentage: 20%