Senior Director, US Regulatory Strategy & Submissions
Initial Therapeutics, Inc.
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 to ensure compliant, timely launches.
The role requires senior scientific expertise, strategic thinking, and strong collaboration with cross-functional teams to deliver regulatory plans that align with global objectives.
#J-18808-Ljbffr$169.5k - $248.6k
...for patients, we invite you to join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the... ...& execution of global regulatory strategies— from portfolio entry through end... ...managementUS FDA OversightOversee all US FDA submissions and agency interactions, including...SeniorLocal areaRemote workRelocationFlexible 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 oversight of regulatory submissions, approvals, and labeling for assigned US products...SeniorLocal area
$169.5k - $248.6k
...for patients, we invite you to join us. Senior Director, Global Regulatory Scientist Purpose The Senior... ...and execute the US regulatory strategy and plan for assigned product(s),... ...quality and efficient regulatory submissions, approvals, and labelling for their...SeniorFull timeLocal areaFlexible hours$93k - $171.3k
Position Summary Senior Consultant, US Global StrategyThe US Global Strategy team is part of our Clients, Strategy, & Growth (CS&G) organization. The Clients, Strategy, & Growth organization is responsible for shaping and developing organization-wide strategies...Senior- ...Lilly in Indianapolis, Indiana, seeks a Senior Director - Counsel, Infectious Disease & Vaccines, Regulatory Legal to lead regulatory strategy across the product lifecycle —from development... ...to practice law in the United States, and bring #J-18808-Ljbffr Jobleads-USSenior
- ...for organizations across industries. Our strategy is to be the reinvention partner of choice... ...$70 billion in FY25 revenue. Visit us at .You Are:Are you a dynamic, inquisitive... ...formal presentations and communications to senior executives.Analytical Thinking: Exhibit intellectual...SeniorFull timeLive inWork at officeLocal areaWorldwide
$198.7k - $391.6k
...Position Summary The Experience Design Strategy Senior Manager is a client-facing consulting leader... ...The Team An evolving customer and regulatory landscape, mounting pipeline of next-gen... ...and organizational performance. #Customer_US #CSD_US Deloitte is committed to...SeniorLocal area$198.7k - $391.6k
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Position Summary Private Equity M&A Strategy & Diligence Senior ManagerOur Deloitte Strategy &... ...range of critical issues brought on by regulatory changes, competition, globalization, advances... ...and collectively. It enables us to leverage different ways of thinking...SeniorOdd jobWork experience placementLocal area$198.7k - $391.6k
Position Summary Pricing and Sales Strategy_ Senior Manager, Strategy, Growth, and Transformation Our Deloitte Customer team empowers... ...optimization, service design, UX design, and customer analytics. Join us to drive impactful customer experiences and market success....SeniorLocal area- ...capability transformation, skills strategy, and workforce performance.You... ...consulting expertise with the senior presence and commercial... ...CHRO alongside your Managing Director, where your ability to build trust... ...to creating 360 value, enable us to help our clients reinvent and...SeniorFull timeLive inWork at officeLocal area
$190.2k - $372k
Position Summary Our Deloitte Strategy & Transactions team helps guide clients through... ...care strategy practice is looking for a senior manager to be a part of this incredible... ...individually and collectively. It enables us to leverage different ways of thinking, ideas...SeniorLocal areaVisa sponsorship- ...learning and sustainability capabilities, our Strategy & Consulting services help architect and... .... Your expertise Advising the CEO and senior-most clients to craft rapid, data-driven,... ...commitment to creating 360 value, enable us to help our clients reinvent and build...SeniorFull timeLive inWork at officeLocal area
$148.5k - $257.4k
...patients, we invite you to join us. This role provides strategic, tactical, and operational regulatory CMC leadership across... ...registrations, and post-approval submissions. This is accomplished through... ...characterization, and control strategies).Knowledge of global CMC regulatory...Flexible hours$177k - $308k
...committed to using its innovation-based strategy to discover, develop and deliver innovative... ...workflows. This role will help position us as an industry leader in AI-enabled drug... ...development while ensuring scientific rigor, regulatory defensibility, and meaningful value...SeniorFlexible hours- ...platforms; creative, media and marketing strategy; and campaign, content and channel orchestration... ..., technology and intelligence. Visit us at: You are: You have proven work... ...Lead multiple workstreams and engage most senior clients day to day as the face of delivery...SeniorFull timeWork experience placementLive inWork at officeLocal area
$199.2k - $273.8k
...apply and will be considered.Meet the TeamJoin Cisco’s Pricing Strategy and Monetization team—an essential part of our Product Organization... ...of hardware and software solutions. Reporting to the Sr. Director of Pricing Strategy and Monetization, you will help build how Cisco...SeniorFull timeTemporary workLocal areaRemote workFlexible hours- ...Jobtailor is seeking a senior Regulatory CMC leader to provide strategic, tactical, and operational oversight across therapeutic modalities... ...the development and implementation of innovative regulatory strategies and platform approaches. Ideal candidates will have 10+...
- Technology Strategy Manager/Sr. Manager, Products IndustryTechnology Strategy, and we design... ..., and a passion for collaborating with senior executives. You love continual learning and... ...commitment to creating 360 value, enable us to help our clients reinvent and build...SeniorFull timeLive inWork at officeLocal area
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...and healthcare financing, enterprise risk management and regulatory compliance, data analytics and business transformation as... ...solutions. Position Summary: Milliman MedInsight is seeking a Senior Product Strategy Manager to lead product strategy and commercialization for...SeniorFull timeWork experience placementRemote workFlexible hours$157.5k - $231k
...patients, we invite you to join us. This role is built for an... ...to everything they do. The Senior Director will spearhead an assigned... ...portfolio, and go-to-market strategy, championing an AI-first culture... ...; understanding of regulatory and compliance considerations...SeniorWorldwideFlexible hours- Technology Strategy Manager/Sr. Manager, Communications, Media & High-Tech IndustryTechnology... ..., and a passion for collaborating with senior executives. You love continual learning and... ...commitment to creating 360 value, enable us to help our clients reinvent and build...SeniorFull timeLive inWork at officeLocal area
$93k - $171.3k
...Summary Join Deloitte’s Finance Transformation group as Senior Consultant, Strategy, Growth, and Transformation, partnering directly with the... ...a difference individually and collectively. It enables us to leverage different ways of thinking, ideas, and perspectives...SeniorRemote workVisa sponsorship- ...Real Chemistry is seeking a Senior Director, Client Experience Media to lead strategic media planning for healthcare clients and guide omnichannel... .... You will collaborate with analytics, activation, and strategy groups to drive business impact, optimize budgets, and #J-1...SeniorRemote work
$148.5k - $257.4k
...provides strategic, tactical and operational regulatory CMC leadership across therapeutic... ...market registrations, and post approval submissions. This is accomplished through a strong... ...implementation of innovative regulatory strategies and platform approaches based on...Remote workRelocation packageFlexible hours$66k - $171.6k
...we invite you to join us. Organization Overview... ...the world. The API EM Senior or Principal Scientist... ...cGMPs, applicable global regulatory manufacturing guidance... ...related to control strategy and manufacturing.Employ... ....Support regulatory submissions with technical input as...SeniorFull timeContract workH1bVisa sponsorshipWork visaFlexible hoursShift workNight shiftWeekend work- ...the intersection of enterprise strategy, commercial growth, operating... ...enterprise-value outcomes.You AreA senior strategy leader who combines... ....The WorkAs an Associate Director, you will lead CEO- and C-suite... ...to creating 360 value, enable us to help our clients reinvent and...Full timeLive inWork at officeLocal area
$93k - $171.3k
...energized by working in high-impact, cross-functional environments? Do you enjoy shaping growth strategy and supporting strategic investment decisions? As a Senior Consultant within US Corporate Development, you will help evaluate and advance Deloitte’s most strategic...SeniorWork at officeLocal areaRemote workWork from homeVisa sponsorship- ...critical role within our growing R&D strategy team to focus on R&D... ...billion in FY25 revenue. Visit us at .Accenture's Life Sciences... ...and a clear path to Managing Director for high performers.You Are:An... ...Heads of R&D functions, and other senior stakeholders.Serve as a guiding...Full timeWork experience placementLive inWork at officeLocal area
$155.6k - $306.8k
Position Summary Our Deloitte Strategy & Transactions team helps guide clients through... ..., and strategic recommendationsAdvising senior client stakeholders on strategic choices... ...individually and collectively. It enables us to leverage different ways of thinking,...Local areaVisa sponsorship
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