Global Regulatory CMC Director Small Molecule Strategy

Eli Lilly

Eli Lilly and Company is seeking a CMC Regulatory Leader in Indianapolis, Indiana. This full-time position requires a B.S. degree in science or engineering, with 10+ years of experience in Regulatory CMC. The role involves providing strategic and operational regulatory leadership across therapeutic modalities to support clinical trials and product registrations. Candidates must have strong leadership, analytical, and communication skills, along with deep technical knowledge in drug development. A remote option may be considered. #J-18808-Ljbffr

Apply

Vacancy posted 10 hours ago

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

Global Regulatory CMC Director - Small Molecule Strategy
...Dormont Manufacturing Co is seeking a Regulatory CMC Leader based in Indianapolis, IN. This... ...operational regulatory leadership across small molecule drug development and manufacturing... ...Candidates should have deep knowledge of global CMC regulatory requirements and a...
Suggested
Full time
Dormont Manufacturing Company
Indianapolis, IN
10 hours 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... ...expedite development of the small molecule portfolio and to support clinical... ...of innovative regulatory strategies and platform approaches based...
Suggested
Full time
Remote work
Relocation package
Flexible hours
Initial Therapeutics, Inc.
Indianapolis, IN
11 hours ago
Global CMC Regulatory Director Biocides/Topicals/Collars
...Elanco Tiergesundheit AG in Indianapolis is seeking a Director for Global CMC Regulatory Affairs. This role requires managing a global regulatory team for Biocides and Pesticides, developing regulatory strategies, and ensuring compliance with global agencies. Candidates...
Suggested
Relocation
Elanco Tiergesundheit AG
Indianapolis, IN
10 hours ago
Scientific Director Synthetic Process Chemistry (Peptides & Small Molecules)
$148.5k - $257.4k
...Scientific Director — Synthetic Process Chemistry (Peptides & Small Molecules)Skip to main contentWe use cookies... ...the world. We are a global healthcare leader... ....Our core commercial strategy centers on traditional... ...platforms.* Familiarity with regulatory CMC requirements for...
Suggested
Full time
Flexible hours
Eli Lilly
Indianapolis, IN
10 hours ago
Senior Director/Executive Director - SMDD Late Stage Small Molecule Chemistry
$156k - $253k
...Overview We are seeking a Senior Director - Late Stage Small Molecule Chemistry to provide... ...teams including Quality, Regulatory, and manufacturing to ensure... ...of SMDD’s technical strategy. Evaluate the organization... ...experience. 10+ years of CMC experience. Direct experience...
Suggested
Full time
Work experience placement
Flexible hours
Eli Lilly and Company
Indianapolis, IN
1 day ago
Director, Global CMC Regulatory Affairs - Biocides/Pesticides, Topicals and Collars
...it all starts with animals! As a global leader in animal health, we are... ...join our team today! Your Role: Director, Global CMC Regulatory Affairs - Biocides/Pesticides, Topicals... ...instrumental in developing regulatory strategies, overseeing submission preparation,...
Summer work
Relocation
Flexible hours
Elanco Animal Health Incorporated
Indianapolis, IN
2 days ago
Director, Global CMC Regulatory Affairs - Biocides/Pesticides, Topicals and Collars
...Director, Global CMC Regulatory Affairs – Biocides/Pesticides, Topicals and Collars At Elanco – it all starts with animals! As a global leader... .... You'll be instrumental in developing regulatory strategies, overseeing submission preparation, and ensuring compliance...
Summer work
Relocation
Flexible hours
Elanco Animal Health
Indianapolis, IN
3 days ago
Associate Director, Regulatory CMC Greater Boston Area
...We are growing our Regulatory Affairs organization... ...professional to support global Regulatory CMC activities across... ...maintenance of CMC regulatory strategies to enable successful... ...with the Senior Director of Regulatory CMC... ...of NCEs / small molecules/biologics/combination...
MBX Biosciences, Inc.
Carmel, IN
10 hours ago
Associate Director, Regulatory CMC - Global Submissions Leader
...biopharmaceutical company in Carmel, Indiana, is seeking a Regulatory Affairs professional to support global regulatory CMC activities. This role involves collaborating on... ...clinical programs and managing CMC regulatory strategies. The ideal candidate will have over 10 years of...
MBX Biosciences, Inc.
Carmel, IN
11 hours ago
Global Regulatory CMC Advisor - Veterinary Biologicals (Hybrid)
...A leading animal health company is seeking an Advisor for CMC Regulatory Affairs – Biologicals in Indianapolis, IN. In this pivotal role, you will provide strategic regulatory guidance to maintain global product registrations and availability, improving overall regulatory...
Elanco
Indianapolis, IN
11 hours ago
Senior Director, Late-Stage Small Molecule Chemistry & Scale-Up
$156k - $253k
Eli Lilly and Company seeks a Senior Director for Late Stage Small Molecule Chemistry to lead a high-performance team in Indianapolis. This role involves... .... The ideal candidate will have over 10 years of CMC experience and a Ph.D. in a relevant field. Competitive...
Eli Lilly and Company
Indianapolis, IN
1 day ago
Director/Senior Director/ Executive Director: Digital Innovation & Technology Strategy - Global
$177k - $308k
...better for people around the world. We are a global healthcare leader headquartered in... ...committed to using its innovation-based strategy to discover, develop and deliver innovative... ...while ensuring scientific rigor, regulatory defensibility, and meaningful value creation...
Full time
Flexible hours
Initial Therapeutics, Inc.
Indianapolis, IN
11 hours ago
Senior Manager, Global Regulatory Affairs
$150.03k - $224.25k
...Position Summary Provides critical support in developing global regulatory strategy, planning and execution of global investigational and... ...members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.)...
Temporary work
Work at office
Local area
Flexible hours
Otsuka America Pharmaceutical Inc.
Indianapolis, IN
1 day ago
Global IP Strategy Director: Patents, Trademarks & More
...senior leader to drive its enterprise-wide intellectual property strategy from Indianapolis, Indiana. The role involves advising... ...IP matters, protecting and enforcing IP assets, and managing a small team of IP professionals. A Juris Doctor (J.D.) with a minimum...
Teradata Corporation (SE)
Indianapolis, IN
4 days ago
Medical Director, Global Medical Strategy
$209.6k - $313.38k
...Company Overview: Otsuka is a global healthcare company driven by... ...and experienced Medical Director of CNS Early Assets, Global Medical... ...to the broader overall TA strategy determined by the Sr.... ...the US healthcare system and regulatory landscape is required for this...
Temporary work
Local area
Flexible hours
Otsuka America Pharmaceutical Inc.
Indianapolis, IN
1 day ago
Sr. Director - Global Regulatory Lead - Neuroscience/Immunology
$169.5k - $248.6k
...around the world. We are a global healthcare leader headquartered... ...The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory... ...global regulatory strategies for product(s) in the assigned... ...GRA central functions, GRA-CMC, GRA-Devices, and regional...
Full time
Local area
Relocation
Flexible hours
Eli Lilly
Indianapolis, IN
3 days ago
Senior Director Global Regulatory Lead - Oncology
...Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) At Lilly, we unite caring... ...implement innovative global regulatory strategies for products in the assigned... ...inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory...
Local area
Eli Lilly
Indianapolis, IN
2 days ago
Head of Strategy & Business Operations, Work Management
$154.5k - $226.6k
...people around the world. We are a global healthcare leader... ...Objectives/Deliverables Operational Strategy & Day-to-Day Execution Own and... ...drive efficiency and meet regulatory, privacy, and quality standards... ...for the Lilly Cares Board of Directors, including preparation for...
Full time
H1b
Visa sponsorship
Work visa
Flexible hours
Initial Therapeutics, Inc.
Indianapolis, IN
2 days ago
Associate Director - Pharmacovigilance (PV) Systems Strategy and Implementation
$115.5k - $169.4k
...around the world. We are a global healthcare leader headquartered... ...purpose of the Associate Director PV Systems Strategy and Implementation is to... ...and Quality to deliver upon regulatory and audit requests. Leads engagement... .... 2+ years implementing small and large systems/...
Full time
H1b
Relocation
Visa sponsorship
Work visa
Flexible hours
Dormont Manufacturing Company
Indianapolis, IN
10 hours ago
Biologics Regulatory Affairs Director | Global Impact
...Elanco Tiergesundheit AG is seeking an Associate Director, Regulatory Affairs – Biologics in Indianapolis, IN. You will lead the regulatory strategy for biologics and vaccine programs. The ideal candidate must have at least 5 years of experience in Regulatory Affairs and...
Relocation
Flexible hours
Elanco Tiergesundheit AG
Indianapolis, IN
11 hours ago
Finance & Strategy Manager, Professional Services - Global Delivery
Finance & Strategy Manager, Professional Services - Global Delivery Join to apply for the Finance & Strategy Manager, Professional Services - Global Delivery role at Salesforce Job Overview We are seeking a Finance & Strategy Manager to join our Global Delivery team at...
3 days per week
Salesforce
Indianapolis, IN
4 days ago
Associate Director, TS/MS Manufacturing CMC Project Management
$117k - $171.6k
...for people around the world. We are a global healthcare leader headquartered in... ...responsible for integrating Manufacturing CMC elements to support molecule commercialization and to manage the... ...CM&C teams in developing strategies and implementing operational plans to...
Full time
Flexible hours
Eli Lilly
Indianapolis, IN
2 days ago
Global Senior Director, Components & Materials Strategy
$163.5k - $239.8k
...Initial Therapeutics, Inc. is seeking a Senior Director for Components and Materials to lead strategic initiatives in Indianapolis. This role involves overseeing the global network for Primary Packaging Components and driving compliance and operational excellence. Candidates...
Initial Therapeutics, Inc.
Indianapolis, IN
1 day ago
Sr Manager Global Contract Compliance Bids & Tenders
$135k - $190k
...by scientists, with many of our 3,300+ global colleagues coming from the laboratory.... ...profitable growth through disciplined contract strategy, bid and tender excellence, and large... ...This position reports to the Senior Director, Global Commercial Operations & Enablement...
Contract work
Part time
Remote work
Work from home
Flexible hours
Danaher Corporation
Indianapolis, IN
4 days ago
Global Cyber Compliance Director, AI-Enabled
$157.5k - $231k
...Lilly is seeking a Senior Director of Global Cyber Compliance in Indianapolis to lead compliance... ...and oversee a multi-framework regulatory environment. The successful candidate... ...define and own the global compliance strategy, apply AI to enhance processes, and ensure...
Initial Therapeutics, Inc.
Indianapolis, IN
11 hours ago
Senior/Executive Director Global Medical Affairs - Breast Franchise
$198k - $356.4k
...people around the world. We are a global healthcare leader... ...role in shaping the scientific strategy and ensuring impactful dissemination... ...and enthusiasm for the molecule and the program through data... ...development to support global regulatory requests (data generation, analysis...
Full time
Flexible hours
Initial Therapeutics, Inc.
Indianapolis, IN
1 day ago
Head of Global Regulatory Advertising and Promotion
...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....
Confidential
Indianapolis, IN
4 days ago
Global Transfer Pricing Manager — Tax Strategy & Compliance
A leading automotive transmission company in Indianapolis is seeking a Transfer Pricing Manager to oversee U.S. international tax compliance and support audit processes. The ideal candidate will have over 7 years of corporate income tax experience, with at least 5 years...
Allison Transmission
Indianapolis, IN
10 hours ago
Associate Director, Global Quality Operations
$150.03k - $224.25k
...Summary The Associate Director, Quality Operations... ..., and optimize global quality system processes... ...effective change management strategies are applied to drive... ...comply with global regulatory requirements (e.g.,... ...exposure to both small molecule and biologics. ~ Strong...
Temporary work
Local area
Flexible hours
Otsuka America Pharmaceutical Inc.
Indianapolis, IN
5 days ago
Senior Director- Global Cyber Compliance
$157.5k - $231k
...people around the world. We are a global healthcare leader... ...Cybersecurity is seeking a Senior Director of Global Cyber Compliance to... ...program that measurably reduces regulatory risk across Lilly's global... ...environment. This leader owns strategy and execution across a complex...
Full time
H1b
Immediate start
Visa sponsorship
Work visa
Flexible hours
Initial Therapeutics, Inc.
Indianapolis, IN
4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory CMC Director Small Molecule Strategy. Be the first to apply!