Associate Director Clinical Regulatory ScientistAssociate Director Clinical Regulatory Scientist (Specialising in Paediatrics)
Our client, a global pharma company, is currently recruiting for an Associate Director Clinical Regulatory Scientist (Specialising in Paediatrics) to join their team on a permanent basis. As Associate Director Clinical Regulatory Scientist, you will develop and execute the regulatory strategy for the US and Canadian markets. This role offers hybrid working.
Responsibilities Develop, Update and Execute US and Canada Registration StrategyInitiate and Update Regulatory Strategy DocumentAssist or lead in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/HC meetings and regulatory trends.Integrate information from the external environment, product specific regulator advice, and other public information (i.e., Advisory Committees) to develop robust, innovative regulatory strategiesReview, summarize, and present information regarding regulator expectations by utilizing agency feedback received by the organisation and knowledge of competitor labellingMonitor upcoming and recent approvals of competitive development programs/plansIntegrate US/CA regulatory strategy into global registration strategyPartner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategyCommunicate and share key information to enable seamless execution of US/Canada regulatory strategyProvide input to clinical program to support market differentiation needsCommunicate the regulatory options and impact on proposed product development plans, seeking Senior Regulatory Scientist and management alignmentLeverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assetsCollaborate with internal teams for the success of the pricing and access strategies through influencing what data is needed and how it is collected on development or product lifecycle planningSupport development and update of labelling strategy to deliver market differentiationInitiate and update Claims Mapping, and Labelling DashboardPartner with regulatory, product and clinical development, commercial and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources (e.g., Claims mapping) and network for alignmentConfirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developmentsUse global labelling strategy to influence the drug development strategyCreate and communicate labelling dashboard to drive internal alignment on labelling strategy and key risksDevelop and Update US and CA labelling, including prescribing information, patient labelling, device labelling (IFU) for new products and indicationsSupport the development of the US/Canadian labelling strategy in collaboration with Senior Regulatory Scientist and project personnelSupport strategic development of US/CA labelling documents for initial submission, line extensions, key changes, and key updates, and provide responses to agency labelling questions. Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labellingSupport development of strategy for submission and amendments for: IND, IDE, NDA/BLA, NDS, PMA/510(k), and de novoDetermine and communicate submission and approval requirements and regulator expectationsGenerate regulatory documents for submissions. Ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate the organisations scientific positionAnticipate, resolve, and communicate key technical, operational, and strategic issues that may impact other development functions or the development teamPropose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systemsLiaise with product and clinical development team and liaison with diagnostic development expertsProvide high quality, timely and decisive regulatory advice that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business developmentCommunicate regulatory risks, potential impact and mitigation plans with development team leadership and regulatory managementCultivate relationships with development teamsRequirements: Bachelor's degree in scientific or health sciences disciplineIndustry-related experience in regulatory affairs and/or drug development experience for a minimum of 5-8 yearsKnowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirableDemonstrated deep knowledge of the drug development process, regulatory/business strategies and plans requiredDemonstrated ability to assess and manage risk in a highly regulated environmentDemonstrated strong written, spoken and presentation communicationDemonstrated negotiation and influence skillsDemonstrated attention to detailDemonstrated effective teamwork skills; able to adapt to diverse interpersonal situationsFor more information, please contact Sinéad Cullen on +353879500821 or ******
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