Global Regulatory CMC Director: Strategy & Submissions

BioSpace, Inc.

Lilly, headquartered in Indianapolis, IN, invites a seasoned Regulatory CMC leader to join our global team. You will shape regulatory strategy across small molecule development, supply chain, and lifecycle submissions, with emphasis on regulatory precedent and global guidelines. In this role, you will guide CMC teams, author and review submissions, and coordinate interactions with health authorities. A remote option may be considered; relocation assistance is provided for ideal candidates. #J-18808-Ljbffr

Apply

Vacancy posted 2 days ago

Similar jobs that could be interesting for youBased on the Global Regulatory CMC Director: Strategy & Submissions in Indianapolis, IN vacancy

Global Regulatory Affairs Director CMC Lifecycle
...Lilly is seeking a Director, GRA-CMCD Lifecycle Innovation... ..., and operational regulatory leadership for post-approval CMC activities across Lilly'... ...This role drives lifecycle strategies, data package quality, and timely submissions with global teams across sites and CMOs...
Suggested
Eli Lilly
Indianapolis, IN
1 day ago
Director, Global Regulatory Affairs - CMC, Lifecycle Innovation
$177k - $281.6k
...to join us. The Director, GRA-CMCD Lifecycle... ...tactical and operational regulatory leadership for post-approval CMC activities across... ...role leads complex global lifecycle regulatory strategies across products and... ...changes while improving submission efficiency and...
Suggested
Full time
Contract work
Flexible hours
Regulatory Toolkit
Indianapolis, IN
2 days ago
Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform Innovation - Synthetic Peptides and Oligonucleotides
$148.5k - $257.4k
..., tactical, and operational regulatory CMC leadership across advanced therapeutic... ..., and post-approval submissions. This is accomplished... ...strong working knowledge of global regulations, guidelines, and... ...characterization, and control strategies). Knowledge of global CMC...
Suggested
Full time
Flexible hours
100 Eli Lilly and Company
Indianapolis, IN
3 days ago
Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform
$148.5k - $257.4k
...around the world. We are a global healthcare leader headquartered... ..., tactical and operational regulatory CMC leadership across... ...registrations, and post approval submissions. This is accomplished through... ...implementation of innovative regulatory strategies and platform approaches...
Suggested
Full time
Remote work
Relocation package
Flexible hours
BioSpace, Inc.
Indianapolis, IN
2 days ago
Senior Director, Regulatory CMC (remote)
$175.5k - $283.8k
...26. Overview As the Senior Director, Regulatory CMC, you will provide strategic and operational... ...initiatives, develop and execute global CMC regulatory strategies, partner with internal and... ..., and oversee CMC regulatory submissions across our portfolio. The ideal...
Suggested
Remote job
Full time
Flexible hours
Jobleads-US
Indianapolis, IN
5 days ago
Senior Director, European Regulatory Strategy Lead
$160.5k - $259.6k
...to Work® in 2026. As the Senior Director, European Regulatory Strategy , you will report to the SVP,... ...pediatric development and regulatory submissions, including pediatric regulatory strategy... ...submissions. Collaborate with global regulatory colleagues to ensure...
Full time
Flexible hours
Regulatory Toolkit
Indianapolis, IN
3 days ago
Global Wellbeing Director: Strategy & Impact
...Deckers Brands is seeking a Director, Global Wellbeing to lead enterprise-wide wellbeing programs, shape a forward-looking strategy, and collaborate with the People & Experience team to elevate the employee experience across the globe. You will guide a small global team...
Deckers Brands
Indianapolis, IN
2 days ago
Global Head of Regulatory Affairs, Roche Diagnostics
$346.64k
...patients across the world. As the Global Head of Regulatory Affairs, you enable and empower your... ...in the delivery of their respective strategies and solutions. You will identify the... ...direction for Global Regulatory Submissions with leadership of teams in Europe,...
Local area
Relocation package
Regulatory Toolkit
Indianapolis, IN
3 days ago
Global Development Leader — Senior Director, OTIF & Strategy
...Elanco is seeking a Senior Director, Global Development Leader to provide strategic and operational leadership for global animal health development programs from research through approval, supply readiness, and launch. You will maximize product value, drive cross-functional...
Jobleads-US
Indianapolis, IN
2 days ago
Remote Regulatory Project Director
...seeking an Associate Director, Regulatory Project Management for... ...will lead regulatory submission planning, cross‑... ...strong communication with global health authorities,... ...Clinical, Nonclinical, CMC, Quality, and... ...to deliver compliant strategies that #J-18808-Ljbffr
Remote work
BioSpace, Inc.
Indianapolis, IN
1 day ago
EU Regulatory Strategy Leader Senior Director
...Lilly is seeking a Senior Director, Global Regulatory Strategy based in the UK with occasional travel to the US. The role focuses on leading European regulatory programs, coordinating interactions with EMA, MHRA, and Swissmedic, and guiding pediatric regulatory strategy...
Regulatory Jobs
Indianapolis, IN
2 days ago
Sr. Director- GQA Global Medical Regulatory Safety
$163.5k - $239.8k
...matters for patients, we invite you to join us. Sr. Director- GQA Global Medical Regulatory Safety Responsibilities This role leads the Global Quality... ...activities. Lead the definition of the quality strategy and GQA audit plans for the areas of responsibility....
Full time
Contract work
Flexible hours
100 Eli Lilly and Company
Indianapolis, IN
3 days ago
Director, Site and CMC Program Management Indianapolis - RayzeBio - IN R1605207 Posted 15 hours ago
$203.39k - $246.46k
## Director, Site and CMC Program ManagementIndianapolis - RayzeBio - INFind... ...emergent biotech with the global expertise and resources of... ...chain, production, quality, regulatory, engineering, and external... ...decision points, risk mitigation strategies, and performance reporting....
Hourly pay
Full time
Temporary work
Part time
For contractors
Summer work
Live in
Work at office
Local area
Immediate start
Remote work
Flexible hours
Jobleads-US
Indianapolis, IN
5 days ago
HRBP Director: Strategy, Leadership & Compliance
...is seeking an HR Business Partner (HRBP) Director to serve as a strategic advisor and... ...into talent, organization, and culture strategies that drive sustainable performance. This... ...assistance, requiring navigating a complex global matrix and mobilizing ONE HR to deliver...
Relocation package
Cummins
Indianapolis, IN
4 days ago
Head of Global Planning Processes
$129.4k - $240.4k
## Head of Global Planning ProcessesApply: Indianapolis: Mannheim: Full time: Posted Today: 202610-126478At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections...
Full time
F. Hoffmann-La Roche AG
Indianapolis, IN
5 days ago
Associate Director of CMC - Quality Assurance
$164.84k - $199.75k
...emergent biotech with the global expertise and resources... ...: The Associate Director of Chemistry, Manufacturing & Controls (CMC) - Quality Assurance develops... ...and analytical) strategies for CMC activities (drug... ...organization. Collaborate with Regulatory to track/own Quality...
Hourly pay
Full time
Summer work
Live in
Local area
Immediate start
Flexible hours
Regulatory Jobs
Indianapolis, IN
1 day ago
Global Product Planning Lead - Pathology & Molecular reagents
$129.4k - $240.4k
...matters.The PositionThe OpportunityAs the Global Product Planning Lead for Molecular and... ...product launches, changeovers, and regulatory transitions.Optimize Distribution Networks... ...international hubs, balancing transport strategies (sea vs. air) to maximize efficiency and...
Full time
Local area
Relocation package
Roche
Indianapolis, IN
1 day ago
Global Talent Acquisition Director Strategy & Impact
...Allegion is seeking a Director of Talent Attraction & Acquisition to lead the US and Canada TA function, shaping strategy, technology roadmaps, and a world-class candidate experience. You will lead a team and partner with executives to drive diverse talent pipelines and...
Hourly pay
Allegion
Carmel, IN
4 days ago
Global Audit and Assurance Technology Risk & Compliance Manager
Position Summary Deloitte Global is the engine of the Deloitte network. Our professionals reach across disciplines and borders... ...standardsLeading coordination across product, technology, vendor, privacy, regulatory, and risk stakeholders, while managing senior team members and...
Visa sponsorship
Deloitte
Indianapolis, IN
2 days ago
Senior Director, Leadership Recruiting & Talent Strategy
...headquartered in Indianapolis, IN, seeks a Senior Director of Leadership Recruiting to lead executive searches, develop talent strategy, and build a high-performing team. The role... ...senior executives in the US, with potential global expansion, reporting to the AVP of Global...
BioSpace, Inc.
Indianapolis, IN
2 days ago
Program Manager, Global Communities
...potential of every human, everywhere, and our mission to reform the global health ecosystem through the power of information and... ...deliverable development to grow a HIMSS global presence using innovative strategies and data analytics to accomplish goals and provide support to...
Work at office
Remote work
Flexible hours
Healthcare Information and Management Systems Society
Indianapolis, IN
5 days ago
Director, Pricing Strategy and Monetization ( Remote)
$233.9k - $330.4k
...where innovation meets impact. We develop pricing strategies, drive monetization initiatives, and optimize... ...unlock cross-sell and upsell potential across our global portfolio.Your ImpactWe are seeking a dynamic Director of Pricing (PM) to own and advance pricing and monetization...
Full time
Temporary work
Local area
Remote work
Flexible hours
CISCO Systems
Indianapolis, IN
2 days ago
Associate Director, Regulatory Project Management
$136.5k - $220k
...integrated project plans for regulatory submissions (e.g., IND, NDA, BLA,... ...Clinical, Nonclinical, CMC, Quality, and... ...Coordinate with Regulatory Strategy Lead to manage interactions with global health authorities, prepare... ...The Associate Director, Regulatory Project Management...
Full time
Remote work
Flexible hours
BioSpace, Inc.
Indianapolis, IN
1 day ago
Global Safety Program Manager
...Lilly, headquartered in Indianapolis, Indiana, is seeking a Global Patient Safety GPS Project Manager to lead the LGSS program and advance the GPS strategy. This role partners with business, IT, Quality, and external vendors to deploy a compliant, scalable safety system...
Worldwide
BioSpace, Inc.
Indianapolis, IN
4 days ago
Associate Director - Global Leadership Development Strategic Business Partner
$127.5k - $187k
...a designated business area. This role sits at the intersection of business strategy and leadership development, diagnosing capability gaps, crafting development priorities, and ensuring Global Leadership Development’s work is directly aligned to what the business needs...
Full time
H1b
Work at office
Visa sponsorship
Work visa
Flexible hours
Eli Lilly
Indianapolis, IN
3 days ago
Managing Director, Strategy & AI
...Managing Director, Strategy & AI About the Company Global strategy consulting firm serving corporations, financial institutions, and enterprise brands Industry Management Consulting Type Privately Held About the Role The Company is seeking a Managing...
Confidential
Indianapolis, IN
1 day ago
Regulatory Affairs Manager - Medical Devices / IVD
...Regulatory Affairs Manager – Medical Devices / IVD Indianapolis, United States | Posted on 09/16/... ...cross-functional teams to support regulatory submissions, product compliance, and regulatory strategies across key global markets, including the United States, European...
Long term contract
Remote work
Dawar Consulting
Indianapolis, IN
4 days ago
CMC QA Lead - Radiopharmaceuticals & Compliance
...RayzeBio is seeking an Associate Director of CMC - Quality Assurance at our Indianapolis, IN facility. You will drive QA strategy across drug substance, API, and analytics for... ...radiopharmaceutical programs, partnering with Regulatory and cross-functional teams. The ideal...
Regulatory Jobs
Indianapolis, IN
1 day ago
Senior CMC QA Lead - Radiopharmaceuticals
...RayzeBio in Indianapolis, IN is seeking an Associate Director of CMC - Quality Assurance to lead QA strategies for drug substance, API, drug product, and... ...expertise and cross‑functional collaboration with Regulatory and QA teams, and is based at the Indianapolis site...
Bristol-Myers Squibb
Indianapolis, IN
3 days ago
Global Manager- Testing and Validation (Indianapolis)
...with SCN ( We are partnering with a global automotive technology company that is... ...working with external test laboratories and regulatory authorities is a plus Job... ...· Develop and implement global testing strategies, methods, and standards to ensure consistent...
Full time
Worldwide
Relocation package
SCN - Search Consulting Network
Indianapolis, IN
1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory CMC Director: Strategy & Submissions. Be the first to apply!