Capleo Global Solutions Pvt Ltd
Regulatory Studio - Associate Director, Precision Medicine & Digital Health
Capleo Global Solutions Pvt Ltd, Short Hills, New Jersey, us, 07078
Regulatory Studio - Associate Director, Precision Medicine & Digital Health Job Title: Regulatory Studio - Associate Director, Precision Medicine & Digital Health
Make your application after reading the following skill and qualification requirements for this position.Location: Short Hills, NJDuration: 6 MonthsMust Have
In vitro diagnostics regulations in precision medicine under US and EU regulationsWorked on drug trials that use a biomarker to select patients into the trial, including understanding clinical trial assay (CTA) requirements with diagnostic partners, sample testing/shipping regulations in different countries, and CDx development requirementsHas built a diagnostic device regulatory strategy plan for a biomarker-driven trialKept up to date on Digital Health technology regulatory requirements and worked on a digital pathology or digital health product in a drugResponsibilities
Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health, and other devices to enhance the value of our pharmaceutical products across therapeutic areasResponsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategiesCo-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiersEnsure consistent positions are presented in responses to global Health Authority (HA) queriesEnsure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plansProvide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlinesContribute to the development of target labelingKey Competencies
Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within Client and across alliance. Experience utilizing leadership techniques to drive a team through the stages of team developmentExperience with developing regulatory strategies in coordination with clinical plans and marketing objectivesExperience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsorExperience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience coordinating communications within teams and across functionsExperience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodiesAbility to apply project management techniques within teams and effectively manage meetingsDemonstrated ability to breakdown complex, scientific content into logical componentsAbility to coordinate global activities, facilitate issue resolution and conflict managementDemonstrated ability to drive quality decision-making and ability to organize/prioritize tasksDemonstrated ability to negotiate with and influence othersUnderstanding of strategic and tactical role for the drug development processUnderstanding of general global regulatory requirements for drugs in developmentUnderstanding of R&D process and specific regulatory responsibilities/deliverables for the company decision pointsDegree / Experience Requirements
Bachelor's degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience.Seniority level Mid-Senior levelEmployment type Full-timeJob function Marketing, Public Relations, and Writing/EditingIndustries Business Consulting and Services
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Make your application after reading the following skill and qualification requirements for this position.Location: Short Hills, NJDuration: 6 MonthsMust Have
In vitro diagnostics regulations in precision medicine under US and EU regulationsWorked on drug trials that use a biomarker to select patients into the trial, including understanding clinical trial assay (CTA) requirements with diagnostic partners, sample testing/shipping regulations in different countries, and CDx development requirementsHas built a diagnostic device regulatory strategy plan for a biomarker-driven trialKept up to date on Digital Health technology regulatory requirements and worked on a digital pathology or digital health product in a drugResponsibilities
Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health, and other devices to enhance the value of our pharmaceutical products across therapeutic areasResponsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategiesCo-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiersEnsure consistent positions are presented in responses to global Health Authority (HA) queriesEnsure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plansProvide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlinesContribute to the development of target labelingKey Competencies
Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within Client and across alliance. Experience utilizing leadership techniques to drive a team through the stages of team developmentExperience with developing regulatory strategies in coordination with clinical plans and marketing objectivesExperience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsorExperience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience coordinating communications within teams and across functionsExperience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodiesAbility to apply project management techniques within teams and effectively manage meetingsDemonstrated ability to breakdown complex, scientific content into logical componentsAbility to coordinate global activities, facilitate issue resolution and conflict managementDemonstrated ability to drive quality decision-making and ability to organize/prioritize tasksDemonstrated ability to negotiate with and influence othersUnderstanding of strategic and tactical role for the drug development processUnderstanding of general global regulatory requirements for drugs in developmentUnderstanding of R&D process and specific regulatory responsibilities/deliverables for the company decision pointsDegree / Experience Requirements
Bachelor's degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience.Seniority level Mid-Senior levelEmployment type Full-timeJob function Marketing, Public Relations, and Writing/EditingIndustries Business Consulting and Services
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