Work Flexibility: HybridKey Areas of Responsibility: Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategiesEvaluates 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 changesEvaluates 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 2 years' experienceMS or RAC(s) preferredKnowledge / Competencies:Project management, writing, coordination, and execution of regulatory itemsPerform technical and scientific regulatory activitiesUsually works with minimum supervision, conferring with superior on unusual mattersAssignments are broad in nature, requiring originality and ingenuityHas some latitude for unreviewed action or decision Travel Percentage: None
