Director, Global Regulatory Affairs - CMC Strategy & Trials
Jobtailor
Jobtailor is seeking a senior Regulatory CMC leader to provide strategic, tactical, and operational oversight across therapeutic modalities and manufacturing technologies. The role requires deep knowledge of global CMC regulatory requirements for clinical trials and product registrations, plus the development and implementation of innovative regulatory strategies and platform approaches.
Ideal candidates will have 10+ years in Regulatory CMC or technical CMC, supporting development and/or
#J-18808-Ljbffr$148.5k - $257.4k
..., tactical, and operational regulatory CMC leadership across advanced therapeutic... ..., supporting clinical trial applications, market... ...strong working knowledge of global regulations, guidelines, and... ...characterization, and control strategies).Knowledge of global CMC regulatory...SuggestedFlexible hours$148.5k - $257.4k
...around the world. We are a global healthcare leader headquartered... ..., tactical and operational regulatory CMC leadership across... ...portfolio and to support clinical trial applications, market registrations... ...of innovative regulatory strategies and platform approaches based...SuggestedRemote workRelocation packageFlexible hours- ...strategic, tactical and operational regulatory CMC leadership across... ...technologies Knowledge of global CMC regulatory requirements... ...guidelines for conducting clinical trials and obtaining global product... ...of innovative regulatory strategies and platform approaches...Suggested
$169.5k - $248.6k
...join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the... ...of global regulatory strategies— from portfolio entry through... ...of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and... ...of experience in regulatory affairs and/or drug developmentORBachelor...SuggestedLocal areaRemote workRelocationFlexible hours$177k - $308k
...people around the world. We are a global healthcare leader... ...to using its innovation-based strategy to discover, develop and deliver... ...while ensuring scientific rigor, regulatory defensibility, and meaningful... ..., Statistics, Regulatory Affairs) to ensure seamless AI integration...SuggestedFlexible hours- ...within a hybrid office model (3 days in the office each week). You will partner with the global tax team and support ASC 740 reporting, transfer pricing and international tax strategies. Qualified candidates hold a CPA license with 5+ years international tax experience...Work at office
$154.5k - $226.6k
...people around the world. We are a global healthcare leader... ...contact serving Global Government Affairs and Import/Export/Trade Compliance... ...guidance on overall business strategies, decisions, and activities... ...not limited to Medical, Legal, Regulatory, Privacy, Protect Lilly,...Full timeH1bWork at officeLocal areaVisa sponsorshipWork visaFlexible hours- ...Establish and execute the US regulatory strategy and plan for assigned products Ensure local plans align with global regulatory strategy and Global Regulatory Plans Lead... ...industry-related experience in regulatory affairs and/or drug development, OR bachelor’s degree...Local area
$169.5k - $248.6k
...patients, we invite you to join us. Senior Director, Global Regulatory Scientist Purpose The Senior Director, Global Regulatory Affairs (GRA), Global Regulatory Scientist (GRS)... ...establish and execute the US regulatory strategy and plan for assigned product(s), ensure...Full timeLocal areaFlexible hours$135k - $190k
...by scientists, with many of our 3,300+ global colleagues coming from the laboratory. It... ...profitable growth through disciplined contract strategy, bid and tender excellence, and large... ....This position reports to the Senior Director, Global Commercial Operations &...Full timeContract workPart timeRemote workWork from homeFlexible hours- ...Lilly is seeking a Senior Director, Global Regulatory Scientist in Indianapolis to lead US regulatory strategy and drive high-quality submissions for assigned products. You will coordinate with the Global Regulatory Leaders, shape labeling, and navigate agency negotiations...
- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology... ...lead the development and execution of the global regulatory strategy for advertising and promotion across its marketed products....
- ...Agriscience is seeking an experienced Global Regulatory Project Manager (GRPM) to join our dynamic... ...Manager (GRPM) translates regulatory strategy and plans into actionable execution by... ...works in close partnership with regulatory affairs and regulatory sciences teams to ensure...Local area1 day per week
- ...clients at the intersection of enterprise strategy, commercial growth, operating model... ...commercial outcomes.The WorkAs an Associate Director, you will lead CEO- and C-suite-level... ...00About AccentureAccenture is a leading global professional services company that helps...Full timeLive inWork at officeLocal area
$198k - $356.4k
...care for them. Our oncology global medical affairs team seeks to understand,... ...in shaping the scientific strategy and ensuring impactful dissemination... ...education, clinical trial awareness, and product positioning... ...to support global regulatory requests (data generation,...Full timeFlexible hours$115.5k - $169.4k
...for people around the world. We are a global healthcare leader headquartered in... ...the world.The purpose of the Associate Director PV Systems Strategy and Implementation is to develop, implement... ...and Quality to deliver upon regulatory and audit requests. Leads engagement...Full timeH1bRelocationVisa sponsorshipWork visaFlexible hours- ...create value at speed for organizations across industries. Our strategy is to be the reinvention partner of choice for our clients and... ....Trusted Partnerships: As trusted partners to business leaders globally, we deliver innovative solutions tailored to unique challenges....Full timeLive inWork at officeLocal areaWorldwide
$199.2k - $273.8k
...considered.Meet the TeamJoin Cisco’s Pricing Strategy and Monetization team—an essential part... ...-sell and upsell potential across our global portfolio.Your ImpactWe are seeking a... ...software solutions. Reporting to the Sr. Director of Pricing Strategy and Monetization, you...Full timeTemporary workLocal areaRemote workFlexible hours- ...8,500 people, 130 U.S. locations, and a global reach, we promise to know you and help you. We are seeking a AI Strategy Director. This role leads the design and delivery... ...with business strategy, risk tolerance, regulatory requirements, and organizational readiness...
- ...Jobot seeks an International Tax Manager for a hybrid role in Indianapolis. You will develop and optimize international tax strategies, ensuring compliance across jurisdictions and supporting complex multinational structures. The role covers planning for mergers, acquisitions...
- ...from possibility to production in real-world enterprise environments every day.Role Overview:Global go to market planning at scale requires disciplined coordination across strategy, operations, and execution. This role shapes how annual and in year planning translates...Full timeWork from homeWorldwideFlexible hoursShift work
$117.5k - $222.99k
...MedInsight is a subsidiary of Milliman; a global, employee-owned consultancy providing... ...financing, enterprise risk management and regulatory compliance, data analytics and business... ...MedInsight is seeking a Senior Product Strategy Manager to lead product strategy and commercialization...Full timeWork experience placementRemote workFlexible hours- Technology Strategy Manager/Sr. Manager, Products IndustryTechnology Strategy, and we design and execute industry-relevant reinventions... ...Washington $87,400 to $253,000About AccentureAccenture is a leading global professional services company that helps the world’s leading...Full timeLive inWork at officeLocal area
$155.6k - $306.8k
Position Summary Our Deloitte Strategy & Transactions team helps guide clients through their most critical moments and transformational... ...in the recruiting process, please direct your inquiries to the Global Call Center (GCC) at ****@*****.***....Local areaVisa sponsorship- ...a critical role within our growing R&D strategy team to focus on R&D reinvention across... ...strong momentum and a clear path to Managing Director for high performers.You Are:An R&D... ...and recruiting.Partner with Accenture’s global industry leads, capability leads, and cross...Full timeWork experience placementLive inWork at officeLocal area
$148.5k - $257.4k
...around the world. We are a global healthcare leader... ...manufacturing, and controls (CMC) of oligonucleotides to... ...activities to support clinical trials, product commercialization, and regulatory submissions of... ...apply impurity control strategies aligned with the current...Contract workLocal areaFlexible hours- ...reinvention, capability transformation, skills strategy, and workforce performance.You are:A... ..., or CHRO alongside your Managing Director, where your ability to build trust, shape... ...00About AccentureAccenture is a leading global professional services company that helps...Full timeLive inWork at officeLocal area
$155.6k - $306.8k
Position Summary Private Equity M&A Strategy & Diligence Manager Our Deloitte... ...credibility and reduce disruption). As a global leader in providing consulting services... ...range of critical issues brought on by regulatory changes, competition, globalization, advances...Odd jobWork experience placementLocal area$198.7k - $391.6k
...Position Summary The Experience Design Strategy Senior Manager is a client-facing consulting... ...The Team An evolving customer and regulatory landscape, mounting pipeline of next-gen... ...centered solutions, both domestically and globally. We are looking for practitioners who will...Local area$163.4k - $322.1k
...Position Summary The Experience Design Strategy Manager is a client-facing consulting leader... ...The Team An evolving customer and regulatory landscape, mounting pipeline of next-gen... ...centered solutions, both domestically and globally. We are looking for practitioners who will...Local areaFlexible hours
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