Work Flexibility: Hybrid or Onsite

Key Areas of Responsibility:

Develops and implements processes involved with maintaining annual licenses, registrations, and listingsReviews and approves advertising and promotion to ensure regulatory complianceAssures post-market regulatory requirements are met (e.g. required reports, supplemental submissions and other post-marketing commitments)Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledgeParticipates in implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g. HCP, patient, distributor, and health authorities)Reports product safety issues to regulatory authorities as required, to comply with local, regional, and global regulationsProvides required information in support of product reimbursement requestsProvides regulatory input and appropriate follow-up for inspections and auditsAssesses 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 compliance

Education / Work Experience:

BS in Engineering, Science, or related degree; or MS in Regulatory Science                 Typically a minimum of 4 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, post-marketing 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
 

Travel Percentage: None