Work Flexibility: Hybrid

Key Areas of Responsibility:

Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies  Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature  Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product complianceAnticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutionsIdentifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
Evaluates proposed products for regulatory classification and jurisdictionDetermines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activitiesProvides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organizationCompares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomesNegotiates with regulatory authorities throughout the product lifecycleIdentifies the need for new regulatory procedures, SOPs, and participates in development and implementationHelps train stakeholders on current and new regulatory requirements to ensure organization-wide complianceAssists other departments in the development of SOPs to ensure regulatory complianceProvides regulatory input and technical guidance on global regulatory requirements to product development teamsAdvises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulationsAssesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulationsEvaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissionsProvides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationshipsIdentifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research processProvides regulatory information and guidance for proposed product claims/labelingEnsures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claimsPrepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelinesMonitors the progress of the regulatory authority review process through appropriate communications with the agencyCommunicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication toolsWorks with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

Education / Work Experience:

BS in Engineering, Science, or related degree; or MS in Regulatory ScienceTypically a minimum of 5 years’ experienceMS or RAC(s) preferred

Knowledge / Competencies:

Strong project management, writing, coordination, and execution of  regulatory itemsEmphasis on technical and scientific regulatory activitiesDemonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance and distributionUnder general supervision, plans, conducts and supervises assignmentsReviews progress and evaluates resultsRecommends changes in proceduresOperates with appreciable latitude for unreviewed action or decisionReviews progress with managementMay direct work of Specialist or Sr. SpecialistSeeks out diverse ideas, opinion, and insights and applies them in the workplaceConnects and relates well with people who think and act differently than oneselfEmbraces scrutiny and accepts feedback as opportunity to learn and improveChooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resourcesNavigates the dynamics, alliances, and competing requirements of the organization or businessWillingly accepts challenging assignments and new career opportunities that stretch and build capabilities

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Travel Percentage: 10%