Director, RDQ Regulatory Quality Risk & Intelligence
$160.6k - $240.8kScorpion Therapeutics
Scorpion Therapeutics is looking for an Associate Director to lead the implementation and maturity of the R&D Quality Regulatory Intelligence & Surveillance (RI&S) process. In this role, you will establish and continuously develop governance models while translating regulatory information into actionable insights. Applicants should possess a Bachelor's degree in Life Sciences and over 8 years of relevant experience. The position offers a competitive salary ranging from $160,600 to $240,800 along with annual bonuses and equity awards. #J-18808-Ljbffr Scorpion Therapeutics
$160.6k - $240.8k
General Position Summary Associate Director responsible for establishing,... ..., and maturing the R&D Quality Regulatory Intelligence & Surveillance (RI&S) process within RDQ and serving as the main quality... ...intelligence into actionable RDQ quality risk insights, recommendations, and...QualityRiskIntelligence$160.6k - $240.8k
## Associate Director, R&D Quality Regulatory & Risk IntegrationApplylocations: Boston, MAtime type: Full timeposted on: Posted... ...implementing, and maturing the R&D Quality Regulatory Intelligence & Surveillance (RI&S) process within RDQ and serving as the main quality point of...QualityRiskIntelligenceSummer workRemote workFlexible hours2 days per week- ...Job Title: Director of Regulatory Affairs Job Description: As the Director... ...teams, including R&D, quality, and marketing, to align product... ...labeling. Regulatory Intelligence and Advocacy: Monitor and... ...policy and practices. Risk Management and Mitigation:...QualityRiskIntelligence
$204k - $245k
...with radical care. The Director, Regulatory CMC is responsible for leading... ...with Technical Operations, Quality, and Supply Chain to ensure... ...and apply regulatory intelligence related to post-approval expectations... ...teams and provide clear, risk-based regulatory input to...QualityRiskIntelligenceFull timeWork at officeFlexible hours3 days per week- ...JOB TITLE: Executive Director, Global Regulatory Affairs DEPARTMENT: Regulatory... ...ensuring consistent, high-quality regulatory strategy... ...including assessment of regulatory risk, probability of success,... ...a high level of regulatory intelligence and competitive awareness,...QualityRiskIntelligence
- Vertex Pharmaceuticals is looking for an Associate Director, R&D Quality Regulatory & Risk Integration in Boston. This role is responsible for establishing... ...key responsibilities such as translating regulatory intelligence into actionable insights and will be involved in cross...QualityRiskIntelligence
$154.4k - $242.55k
...This role is within the Global Regulatory Affairs (GRA) Chemistry... ...precedents and other regulatory intelligence beyond regulations. Strong analytical... ...documents, storyboards, risk assessments, etc.) and... ...Analytical Development, Production, Quality Assurance can be considered)....QualityRiskIntelligenceMinimum wageTemporary workLocal areaRemote workWorldwide- Job Title Executive Director, Regulatory Operations and Submission Management... ...for ensuring submission quality, compliance with current regulations... ...proactively identifying risks and mitigation strategies.... ...regulatory operations intelligence regarding evolving global electronic...QualityRiskIntelligence
$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime... ...conducting regulatory CMC intelligence activities.**Key Responsibilities... ...input and support to quality-related activities, including... ...identifies regulatory CMC risks, ensuring timely...QualityRiskIntelligenceMinimum wageFull timeLocal areaFlexible hours$146.96k - $210.1k
...support in developing global regulatory strategy, planning and execution... ...need and obtains regulatory intelligence, researches precedent... ...accurate, compliant, and high-quality to allow for smooth and expeditious... ...issues, scope progress and risks throughout the project lifecycle...QualityRiskIntelligenceTemporary workWork at officeLocal areaFlexible hours$145.5k - $205k
...Are The Associate Director, Corporate Compliance... ...initiatives, improving data quality and process... ...addressing operational and regulatory challenges with thoughtful... .... Third-Party Risk Program Development: Play... ...knowledge of artificial intelligence concepts and...QualityRiskIntelligenceWork at officeRemote work$190k - $240k
...Reporting to : Executive Director, Regulatory Science Orchard Therapeutics... ...Help identify regulatory risks, develop mitigation... ..., analyze, and disseminate intelligence on US regulatory matters that... ...the ability to produce high-quality regulatory documents. Ability...QualityRiskIntelligenceOdd jobFull timeLocal area- .... We’re building for greater intelligence, autonomy, and speed. For deeper... ..., CA. About the role: Quality is how Lumafield earns trust... ...contact for customer audits, regulatory body inspections, and... ...refine processes and mitigate risks. About you: An Experienced...QualityRiskIntelligenceFull timeWork at officeFlexible hours
- ...The Director of Regulatory Affairs provides strategic and operational leadership to the development... ...timing, logistics and operational. Prepare risk assessment profiles for regulated... ...activities. Participate in regulatory intelligence gathering activities and maintain knowledge...RiskIntelligence
$245k - $300k
...seeking an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global... ..., Pharmacovigilance, CMC, Nonclinical, Quality, and Executive Leadership to advance innovative... ...programs, scenario plans, and risk mitigation plans. Lead the preparation,...QualityRiskLocal area$210k - $270k
...Summary: Oversees and leads the Regulatory Affairs function to ensure global... ...limited to: U.S. FDA 21 CFR Part 820 (Quality Management System Regulation (QMSR), ISO... ...requirements Maintain regulatory intelligence program to monitor and implement new or...QualityIntelligenceHourly payWork at officeLocal areaFlexible hours$270k - $330k
...The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic... ...or globally, and performs Regulatory Intelligence for relevant disease areas,... ...strategiesBe responsible for ensuring potential risks have been identified and mitigation...RiskIntelligenceTemporary workLocal areaWorldwideFlexible hours- ...seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US... ..., preparation, and submission of high‑quality regulatory documents to FDA, including... ...accountable team culture. Anticipate regulatory risks across regions and proactively design...QualityRiskWork at officeLocal area3 days per week
$177k - $278.08k
...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...requirements. Apply science‑ and risk‑based approaches, guided by ICH Q12 principles... ...on precedents and other regulatory intelligence as well as regulations and guidelines....RiskIntelligenceMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$209.35k - $258.6k
...are all in, are you? Job Summary The Director, Regulatory Affairs - Labeling is a highly visible... ...to navigate ambiguity and regulatory risk, have deep expertise in FDA labeling regulations... ...labeling documents. Regulatory Intelligence & Policy Leadership Proactively...RiskIntelligenceWork at officeLocal areaRelocationFlexible hours$238k - $374k
...therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will... ...device/combination where applicable, quality, clinical, and manufacturing) to... ...starting material strategy, impurity risk, raw material/supply risk). Anticipates...QualityRiskFull timeTemporary workLocal areaWorldwide- SwiftCruit is seeking a Director, Risk Intelligence and Analytics to enhance biopharmaceutical manufacturing strategies. This hybrid role aims to... ...data, supporting decision-making across engineering, quality, and supply chain. The candidate should have over 12 years...QualityRiskIntelligence
$185.6k - $278.4k
General Summary The Regulatory Labeling Director will lead the strategic development of global labeling... .... Strong attention to detail with a quality‑driven mindset and strong... ...technology, automation, competitive intelligence and changes in the regulatory environment...QualityIntelligenceRemote jobFull timeLocal area2 days per week- ...design and manage a high-performing supply chain. Responsibilities include supplier strategy, market intelligence, and risk mitigation while ensuring supplier quality and accountability. The ideal candidate will have over 10 years of experience in supply chain roles and...QualityRiskIntelligence
- ...experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing... ..., expedited pathways, regulatory risk assessment, CMC, nonclinical and... ...mentor junior staff. Deliver high-quality regulatory recommendations,...QualityRisk
- ...Lead development and implementation of regulatory strategies for pure device and drug-device... .... Maintain and communicate CMC/quality guidance and regulations (Human Factors)... ...communicate device/combination regulatory risks; support device-related global submissions...QualityRiskNight shift
- ...supply chain. You will own supplier strategy, market intelligence, risk mitigation, supplier quality, and PO execution across critical programs,... ...with Engineering, Quality, and Manufacturing to meet regulatory and production needs, lead make-buy decisions, and drive...QualityRiskIntelligence
$160k - $240k
...Pharmaceuticals is seeking an exceptional Global Regulatory Lead who embodies our organizational... ...Conduct literature searches and gather intelligence to support strategic decision-making... ...adapting accordingly) Essential Qualities Strategic yet hands-on: You can...QualityIntelligenceWork at officeShift work$212k - $333.19k
...patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be... ...types are executed on time with high quality, including major submissions (NDA/BLA/... ...solutions and strategies, including risk mitigation strategies. Must work well...QualityRiskMinimum wageTemporary workLocal areaWorldwide$238k - $374k
...to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...spanning device, combination product, quality, clinical, development and... ...generation, usability/human factors, risk management, and value messaging to regulatory...QualityRiskMinimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide
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