Global Regulatory Lead - Biologics & Vaccines
Elanco Tiergesundheit AG
Elanco Tiergesundheit AG is seeking a Regulatory Affairs Lead in Indianapolis, Indiana. This strategic role involves designing regulatory pathways for biologics and vaccines, engaging with global health authorities like the FDA and EMA, and leading cross-functional teams to streamline regulatory submissions. The ideal candidate has a strong background in regulatory affairs, particularly within the life sciences sector, and will influence decisions across departments. Join us in advancing health and well-being for animals! #J-18808-Ljbffr
- ...all starts with animals!As a global leader in animal health, we... ...– join our team today!The biologics space in Animal Health is... ...We are seeking a strategic Regulatory Affairs Lead to serve as the primary regulatory... ...our global biologics and vaccine portfolios.If you are a...RegulatoryWorldwideShift work
- ...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...RegulatoryRelocationFlexible hours
- ...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...Regulatory
$106k - $197k
...F. Hoffmann-La Roche AG is looking for a Regulatory Affairs expert in Indianapolis to oversee regulatory documentation and submissions. The role entails managing global submissions and developing innovative strategies to navigate regulatory environments. Candidates should...Regulatory- ...A global healthcare leader based in Indianapolis is seeking a Senior Director of Global Regulatory Affairs. This role involves developing innovative regulatory strategies for product lines while leading the Global Regulatory Team. Candidates should have a strong background...Regulatory
$123k - $180.4k
...Therapeutics, Inc. is looking for an Associate Director / Director, Global Intake and Triage Leader to provide operational leadership for... ...analytical and communication skills to ensure compliance with regulatory guidelines. A full benefits package and competitive salary of $...Regulatory- ...Initial Therapeutics, Inc. seeks an experienced regulatory CMC leader in Indianapolis, IN. This position involves providing strategic oversight... ...small molecule drug development and ensuring compliance with global regulations. The successful candidate will have over 10 years...RegulatoryRemote workRelocation package
- ...Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world...RegulatoryLocal area
$169.5k - $248.6k
...make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana... ...: The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative...RegulatoryFull timeLocal areaRelocationFlexible hours- Corteva Agriscience seeks a Global Regulatory Project Manager in Indianapolis, Indiana. This role entails managing regulatory plans, leading projects across R&D stages, and ensuring timely submissions and market access. The ideal candidate has a bachelor’s degree in a...Regulatory
$249.97k - $388.13k
...Position Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader responsible for driving the global value evidence... ...RWE, and other evidence generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate the...RegulatoryTemporary workLocal areaFlexible hours- ...Associate Director, Regulatory Affairs – Biologics At Elanco – it all starts with animals! As a global leader in animal health, we are dedicated to... ...Regulatory Affairs – Biologics, you will lead regulatory strategy for biologics and vaccine programs supporting Animal Health...RegulatorySummer workRelocationFlexible hours
- ...starts with animals! As a global leader in animal health, we... ...! Your Role: Advisor, CMC Regulatory Affairs - Biologicals As the Advisor, CMC Regulatory... ...commitments, and lead commitment responses Drive... ...experience within a veterinary vaccine or biological manufacturing...Regulatory
- ...reports to, and is supervised by, the Global Regulatory Affairs Leader. As member of a Global SAT... ..., collaboration and negotiation. Leads global regulatory teams and supports regional... ...with specialization in agriculture, biology, genetics, chemistry, or equivalent discipline...RegulatoryLocal area
- ...A leading biopharmaceutical company in Carmel, Indiana, is seeking a Regulatory Affairs professional to support global regulatory CMC activities. This role involves collaborating on submissions for clinical programs and managing CMC regulatory strategies. The ideal candidate...Regulatory
$123k - $180.4k
...Lilly and Company is seeking an Associate Director / Director, Global Intake and Triage Leader in Indianapolis, Indiana. The role involves leading global operations for case intake and triage, ensuring regulatory compliance, and managing a team of leaders. Candidates...Regulatory- ...Corteva Agriscience is looking for a Global Regulatory Leader based in Indianapolis, Indiana, to guide regulatory strategies pivotal to product... ...and regulatory experience. Key responsibilities include leading global regulatory strategies and managing regulatory budgets...Regulatory
- A leading agricultural cooperative in Indianapolis is looking for a Crop Protection Procurement Lead to develop sourcing strategies... ...negotiating with suppliers, managing inventory, and ensuring regulatory compliance. The company offers health benefits, a 401(k) plan,...Regulatory
- The Planet Group is seeking a Workday Payroll Lead to join their dynamic team. In this role, you will implement and configure enterprise... ...will lead projects while providing expert guidance on payroll regulatory requirements, and you will work collaboratively to achieve...RegulatoryRemote job
$127.5k - $193.6k
...better for people around the world. We are a global healthcare leader headquartered in... ...execution by translating policy, quality, and regulatory requirements into harmonized, executable... ...Serve as a compliance enablement lead for Thought Leader External Engagement. Partner...RegulatoryFull timeH1bWork at officeLocal areaVisa sponsorshipWork visaFlexible hours$123k - $180.4k
...better for people around the world. We are a global healthcare leader headquartered in... ...Operational Leadership - Intake and Triage Lead global operations for case intake from... ..., literature, digital/social media, regulatory authorities, business partners, and patients...RegulatoryFull timeLocal areaRemote workFlexible hours$148.5k - $257.4k
...people around the world. We are a global healthcare leader... ...strategic, tactical and operational regulatory CMC leadership across therapeutic... ...product lifecycle planning. Leads preparation, critical review,... ..., Analytical Sciences, Biology, or similar. 10+ years of Regulatory...RegulatoryFull timeRemote workRelocation packageFlexible hours$121.5k - $198k
Advisor/Senior Advisor Global Regulatory Affairs CMC - Post Approval - Synthetic Molecule Drug Join... ...completion of submission milestones leading to health authoring approval. Develop... ...Chemical Engineering, Analytical Sciences, Biology, Biochemistry, or similar. 7+ years of...RegulatoryFull timeRemote workWorldwideFlexible hours- ...starts with animals! As a global leader in animal... ...development and launch of new biological drug substances in an... ...be responsible for leading downstream process... ...source documents for regulatory submissions; respond to... ..., pharmaceuticals, or vaccines. Strong interpersonal...RegulatorySummer workRelocationFlexible hours
- ...A global healthcare leader based in Indianapolis is seeking an experienced Environmental Compliance Professional to support manufacturing sites. The role involves developing permitting strategies, ensuring compliance with environmental regulations, and providing strategic...
- ...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...RegulatoryRelocation
$177k - $281.6k
...around the world. We are a global healthcare leader... ...formulations such as vaccines, lipid nanoparticles,... ...motivated scientific lead with deep, hands-on experience... ...strategies and regulatory submissions supporting... ...expectations (FDA CBER, EMA biologics, WHO TRS) and...RegulatoryFull timeFlexible hours$150.03k - $224.25k
...Director, Quality Operations will lead initiatives that drive... ...management practices, and optimize global quality system processes... ...operations comply with global regulatory requirements (e.g., FDA, EMA,... ...exposure to both small molecule and biologics. ~ Strong knowledge of GxP...RegulatoryTemporary workLocal areaFlexible hours$157.5k - $231k
...Lilly is seeking a Senior Director of Global Cyber Compliance in Indianapolis to lead compliance transformation and oversee a multi-framework regulatory environment. The successful candidate will define and own the global compliance strategy, apply AI to enhance processes...Regulatory- ...A global agricultural science company is seeking a Senior Investigative Ecotoxicologist in Indianapolis. The role involves leading ecotoxicology strategies for new crop protection products, providing... ...five years of experience in regulatory ecotoxicology. Join us to make a...Regulatory
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