R&D Quality: Regulatory Intelligence & Risk Lead
Vertex Pharmaceuticals Inc (US)
Vertex Pharmaceuticals Inc (US) is seeking an Associate Director for R&D Quality Regulatory & Risk Integration in Boston. This role will lead the establishment and maturation of the R&D Quality Regulatory Intelligence & Surveillance process while serving as a key point of contact for Regulatory Affairs. The position focuses on integrating external regulatory intelligence, enhancing quality risk management, and ensuring inspection readiness, working closely with cross-functional teams. A strong background in quality and regulatory processes is required, along with 8+ years of industry experience. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)
- Vertex Pharmaceuticals is looking for an Associate Director, R&D Quality Regulatory & Risk Integration in Boston. This role is responsible for... ...manage key responsibilities such as translating regulatory intelligence into actionable insights and will be involved in cross-...QualityRiskRegulatoryIntelligence
$87.45 per hour
...technologies and artificial intelligence, to strengthen... ..., the individual leads therapeutic area... ...TVPs and identify regulatory opportunities for... ...satisfaction and quality‑of‑life studies,... ...Sciences with a strong R&D track record.... ...strategies, benefit‑risk demonstration...QualityRiskRegulatoryIntelligenceHourly payContract work$160.6k - $240.8k
Job Summary Associate Director, R&D Quality Regulatory & Risk Integration is responsible for establishing, implementing, and maturing the R&D Quality Regulatory Intelligence & Surveillance (RI&S) process within RDQ and serving as the main quality point of contact for Regulatory...QualityRiskRegulatoryIntelligenceRemote workFlexible hours2 days per week$214.9k - $358.1k
...translate science of R&D into value for... ...evidence generation, leading global launches,... ...that improve the quality, consistency, and... ...portfolio opportunities, risks, and investment... ..., and Competitive Intelligence colleagues to... ...and statutory or regulatory clarification, which...QualityRiskRegulatoryIntelligencePermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation packageShift work- ...are positioned for regulatory approval and... ...Leadership Define and lead the late‑stage development... ..., competitive intelligence, and patient... ...interpretation, and benefit‑risk assessments.... ..., and ensure high‑quality study conduct... ...Contribute to broader R&D leadership...QualityRiskRegulatoryIntelligenceShift work
$41 - $54 per hour
...operations. ABOUT THE JOB The R&D Lead Technician orchestrates the... ...for the daily success, quality, and timely completion of all... ...provider to conduct pre-employment risk, integrity, and due... ...service provider provides risk-intelligence services that may include analysis...QualityRiskIntelligenceHourly payFull timeWork experience placementImmediate startFlexible hours- ...partners with the PDC Lead to convert asset... ..., align clinical, regulatory, medical, access,... ...governance, risk, timelines, and budgets... ...momentum and enable high-quality delivery. We... ...across R&D and Commercial without... ...utilizes artificial intelligence (AI) tools as part...QualityRiskRegulatoryIntelligenceHourly payLocal area
$216k - $324k
...located at our dynamic R&D site in Boston,... ...process. As the lead ambassador for the... ...and efficacy for regulatory approval plus value... ...on time, cost and quality, working with functional... ...and transparent risk, opportunity and... ..., competitive intelligence, KOL and payer insights...QualityRiskRegulatoryIntelligenceFull timeTemporary workWork at officeFlexible hours3 days per week$212k - $333.19k
...and the resources of a leading pharmaceutical company.... ...times and improve design quality Enable decision-... ...half-life, immunogenicity risk, and expression yield... ...business acumen including regulatory (BLA/MAA pathway) and... ...future operating models in R&D Takeda...QualityRiskRegulatoryMinimum wageFull timeTemporary workLocal areaRemote work- The Lead, Decision Data & Intelligence Enablement plays a critical role in enabling enterprise... ...‑making, including data quality standards, trust indicators... ...‑solving, anticipating risks and roadblocks and driving... ...Experience in enterprise portfolio, R&D, or pharma decision‑making...QualityRiskIntelligenceLocal area
- ...end of the decade. Our R&D focuses on discovering... ...Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution... ...(R&D, manufacturing, quality assurance) to ensure compliance... ...engagements. Identify risks and propose mitigation...QualityRiskRegulatoryLocal area
- ...Job Title: Director of Regulatory Affairs Job... ...regulatory processes, you will lead the development and... ...functional teams, including R&D, quality, and marketing, to... .... Regulatory Intelligence and Advocacy: Monitor... ...policy and practices. Risk Management and Mitigation...QualityRiskRegulatoryIntelligence
- ...Operations to build and lead the end-to-end... ...-velocity, high-quality trial execution across... ...-party enrollment intelligence, public trial... ...trial monitoring and risk-based monitoring (... ...'s clinical and R&D leadership, collaborating... ...trial designs Regulatory — to ensure...QualityRiskRegulatoryIntelligence
$185k - $210k
...Job Description The US Regulatory Strategy Lead is responsible for all... ...regulatory strategies, including risk assessments, mitigation... ...efforts to ensure timely and quality submissions of major application... ...skills with high emotional intelligence ~ Must be a great team...QualityRiskRegulatoryIntelligenceOdd jobTemporary workWork experience placement$145.6k - $270.4k
Role Overview The Lead, Decision Data & Intelligence Enablement plays a critical role in... ...Establish and maintain data quality standards and trust indicators... ...clear communication of risks, confidence levels, and systemic... ...in enterprise portfolio, R&D, or pharma decision‑making...QualityRiskIntelligenceLocal area- Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge, MA... ...bold, AI-powered research. In R&D, you’ll drive breakthroughs... ...opportunities, take thoughtful risks, accept challenges, and... ...wellbeing benefits including high-quality healthcare, prevention and wellness...QualityRiskRegulatory
$154.4k - $242.55k
...looking, world-class R&D organization that... ...within the Global Regulatory Affairs (GRA)... ...supervision, develops and leads the execution of... ...other regulatory intelligence beyond regulations... ..., storyboards, risk assessments, etc.)... ...Development, Production, Quality Assurance can be...QualityRiskRegulatoryIntelligenceMinimum wageTemporary workLocal areaRemote workWorldwide$103.5k - $162.69k
...Description Title: Manager, Quality Systems & Data Analytics, R&D GMP Quality... ...emerging quality risks, compliance trends,... ...quality, patients, or regulatory outcomes. You will... ...Quality. You will lead the development of... ...contribute: Quality Intelligence & Advanced Analytics...QualityRiskRegulatoryIntelligenceMinimum wageFull timeTemporary workLocal areaWorldwide- ...Atopic Dermatitis Medical Lead Location: Cambridge... ...-powered research. In R&D, you'll drive... ...the highest ethical, regulatory, and scientific standards... ...clear protocols, and quality oversight. Co-develop... ...insights, competitive intelligence, and RWE in collaboration...QualityRegulatoryIntelligenceWorldwide
$137k - $215.27k
...Plasma-Derived Therapies (PDT) R&D Organization is dedicated to... ...complex diseases. As Manager Regulatory Lead you will be accountable for... ...creation and submission of high‑quality, compliant regulatory... ...develop solutions to identified risks, discussing these with the team...QualityRiskRegulatoryOdd jobTemporary workLocal areaFlexible hours$177k - $278.08k
...forward‑looking, world‑class R&D organization that unlocks innovation... ...Takeda as a Director, Global Regulatory Lead Oncology where you will be... ...executed on time with high quality, including major submissions... ...and strategies, including risk mitigation strategies. Takeda...QualityRiskRegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide$136.4k - $253.2k
...Science is recognized as a leading hub for top industry... ...workforce to deliver regulatory commitments across the... ...ensuring the delivery of high-quality, regulatory-compliant... ...addressing potential risks to support internal... ...experience in pharmaceutical R&D or a regulated...QualityRiskRegulatoryLocal areaRelocation package$130.8k - $209.4k
...primarily focus on Regulatory Health Authority... ...activities across R&D. The appointee will... ...support regulatory intelligence activities,... ...teams to create a quality culture within Moderna... ...inspections, site risk assessments and clinical... ...of effectiveness. Lead and manage post‑...QualityRiskRegulatoryIntelligenceLocal area$212k - $333.19k
...forward-looking, world-class R&D organization that unlocks innovation... ...as a Senior Director, Global Regulatory Lead - Oncology, where you will be... ...executed on time with high quality, including major submissions... ...and strategies, including risk mitigation strategies. Must...QualityRiskRegulatoryMinimum wageTemporary workLocal areaWorldwide$218.4k - $327.6k
...Kidney Disease) Disease Area Lead represents BSMO at the GKD... ...Sciences, CMTO, Quality, Supply Chain, Regulatory, Finance, and other relevant... ...governance, planning, and risk discussions. Provide integrated... ...functional alignment including R&D, Pharmaceutical Sciences, Regulatory...QualityRiskRegulatoryRemote workFlexible hours2 days per week$224.9k - $404.6k
...opportunity for a seasoned Quality executive to shape... ...Moderna’s global R&D Quality strategy... ...end-to-end regulatory compliance, scientific... ...inspections, and leading a high-performing... ...areas.* Embed risk-based quality management... ..., regulatory intelligence, and inspection readiness...QualityRiskRegulatoryIntelligenceTemporary workWork at officeLocal areaWork from homeWorldwide$177k - $278.08k
...Clinical Pharmacology Lead in our Cambridge,... ...through our R&D-driven market leadership... ...artificial intelligence and automation.... ...decisions and external regulatory interactions. Represents... ...evaluate Benefit-Risk associated with... ...with high quality and efficiency....QualityRiskRegulatoryIntelligenceMinimum wageFull timeTemporary workWork experience placementWork at officeLocal areaRemote work- ...Director, Global Program Team Lead is responsible for... ...within and outside R&D. The GPTL should stimulate... ...robust discussions of risk identification and mitigation... ...with adherence to quality, excellence and... ...influence local and global regulatory, scientific, and commercial...QualityRiskRegulatoryTemporary workWork at officeLocal areaWorldwide
$212k - $333.19k
...forward‑looking, world‑class R&D organization that unlocks... ...role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...filings are of high quality and right the first time. Responsibilities... ...device‑related regulatory risks, ensuring timely...QualityRiskRegulatoryFull timeTemporary workLocal areaWorldwideNight shift$145k - $165k
...Lead Technical Recruiter Later is the world's most intelligent influencer marketing company, built to give brands... ...to leaders across R&D, designing and executing... ...that prioritize candidate quality, speed, and experience... ...: You anticipate risks and opportunities, connect...QualityRiskIntelligencePermanent employmentLocal areaRemote work
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