Associate Director, Regulatory CMC - Global Submissions Leader
MBX Biosciences, Inc.
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 will have over 10 years of pharma or biotech experience and at least 7 years directly in regulatory CMC. This is a chance to contribute to significant development efforts in a dynamic biotech setting. #J-18808-Ljbffr MBX Biosciences, Inc.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Associate Director, Regulatory CMC - Global Submissions Leader in Carmel, IN vacancy
- ...We are growing our Regulatory Affairs organization... ...professional to support global Regulatory CMC activities across... ...enable successful global submissions and ongoing clinical... ...with the Senior Director of Regulatory CMC... ...was founded by global leaders with a transformative...Suggested
- ...Associate Director, Regulatory Affairs – Biologics At Elanco – it all starts with animals! As a global leader in animal health, we are dedicated to innovation... ..., and regulatory submissions. Experience in Animal Health... ...in Biologics CMC Regulatory Affairs Familiarity...SuggestedSummer workRelocationFlexible hours
Elanco Animal Health
Indianapolis, IN2 days ago $123k - $180.4k
...people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana... ...around the world. Purpose The Associate Director / Director, Global Intake and Triage... ...literature, digital/social media, regulatory authorities, business partners, and...SuggestedFull timeLocal areaFlexible hours$117k - $171.6k
...around the world. We are a global healthcare leader headquartered in Indianapolis... ...integrating Manufacturing CMC elements to support... ...Manufacturing Technical Agenda and pre submission deliverables to enable... ...& mentor team members and associates. Gain and share learning and...SuggestedFull timeFlexible hours- 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...SuggestedFull timeRemote work
$150.03k - $224.25k
...critical support in developing global regulatory strategy, planning and... ...marketed prescription drug submissions and manages lifecycle activities... ...provides an assessment of the associated regulatory challenges to the... ...team (GRL, regional leads, CMC-RA, labeling, medical...Temporary workWork at officeLocal areaFlexible hoursOtsuka America Pharmaceutical Inc.
Indianapolis, IN8 days ago$160k - $190k
21GRAMS- Associate Creative Director, Copy At Real Chemistry, making the world a healthier place isn... ...our people are impact-obsessed. As a global agency, we provide a full suite of... ...internally and externally Manage awards submissions and case studies for brand...Work experience placementLocal areaReal Chemistry
Carmel, IN8 days ago$115.5k - $169.4k
...strategies across therapeutic areas and globally in collaboration with cross-functional... .... Lead and support product-specific regulatory interactions related to risk management... ...responsibilities of the EU Qualified Person and associated regulatory expectations. Provide...Full timeLocal areaFlexible hoursEli Lilly
Indianapolis, IN3 days ago- ...humankind. Corteva Agriscience is looking for an experienced Global Segment Finance Leader . This is a position that supports Global Segment... ...direction received from Global Operations Finance Director, Global Segment Finance Leader and Global Segment Leaders...Permanent employmentWork at officeLocal areaVisa sponsorshipFlexible hours
Corteva Agriscience
Indianapolis, IN4 days ago - ...rewarded for your good work. We are currently looking for a Associate Community Manager to join our on-site community team to help support... ...Assist the Property Manager with accurate and timely report submission Accurately prepare and submit communications to the...Contract workFor contractorsWork at officeLocal areaFlexible hoursWeekend work
$110k - $160k
Belden is looking for an SAP GTS Analyst to lead the design and configuration of SAP Global Trade Services. This role will ensure compliance in global fulfillment and export operations. Candidates should have a Bachelor’s degree and over 5 years of hands-on experience...Remote job$115.5k - $184.8k
Initial Therapeutics, Inc. in Indianapolis seeks an experienced Global Waste Management professional to provide strategic and technical expertise in advancing waste management standards and compliance. The ideal candidate will possess a bachelor's degree and over 10 years...$127.5k - $187k
...You will own the monthly global production plan for Lilly's KwikPen... ...planners, quality teams, regulatory functions, and business unit... ...master data integrity in SAP and associated planning systems Reconcile... ...or capacity analyses to director-level and above stakeholders...Full timeH1bVisa sponsorshipWork visaFlexible hoursShift workEli Lilly
Indianapolis, IN3 days ago$249.97k - $388.13k
...Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader responsible for driving the... ...initiatives to support regulatory, HTA, and payer submissions, and demonstrate the differentiated... ...scientific/professional associations etc. ~ Deep...Temporary workLocal areaFlexible hoursOtsuka America Pharmaceutical Inc.
Indianapolis, IN9 days ago- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology... ...and promotion across its marketed products. This senior leader will be a key member of the extended Regulatory Leadership...
$123k - $180.4k
We are seeking an Associate Director - Technical Services/Manufacturing... ...cGMPs and relevant regulatory, validation, and... ...teams, and global contract manufacturers... ...controls, regulatory submissions, expert opinions, validations... ...issues to senior leaders in a timely fashion....Full timeContract workTemporary workFlexible hoursShift workNight shiftWeekend work$91k - $147.2k
...of Companies is recruiting for an MTST Global Finance Reporting Lead - Endomech and Energy... ...will be considered as a single submission. At Johnson & Johnson,we believe health... ...position provides high visibility to senior leaders as well an opportunity to impact the...Full timeTemporary workLocal areaRemote workWorldwideJohnson & Johnson
Indianapolis, IN8 days ago$123k - $180.4k
The Associate Director, Biologics Process Engineering provides leadership and direction to... ...including investigations, change controls, regulatory submissions, expert opinions, validations,... .../IND‑relevant inspections. Network globally to share best practices, control strategies...Permanent employmentFull timeFlexible hoursWeekend work$126k - $184.8k
...Associate Director, International Tax At Lilly, we unite caring with discovery to make... ...people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana... ...and analyzing U.S and foreign regulatory environment, supporting audit controversy...Full timeWorldwideVisa sponsorshipWork visaFlexible hoursEli Lilly
Indianapolis, IN3 days ago$85k - $95k
...Associate Account Director (Healthcare Communications) At Real Chemistry, making the world a healthier place isn't just an aspiration—it's our... ...innovation thrives and our people are impact-obsessed. As a global agency, we provide a full suite of services across...Work experience placementLocal areaRemote workReal Chemistry
Carmel, IN5 days ago- Private Credit Agency Services, Associate Director Location: Carmel, US ABOUT US As a world leading... .... Identify and develop key leaders in the group, build upon individual strengths... ...resources from LinkedIn Learning. Our global benefits also include: Support for professional...Work experience placementFlexible hours
$123k - $180.4k
...people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana... .... The Quality Control (QC) Associate Director (AD) Analytical Sciences is responsible... ...approve documents as required. Support regulatory inspections and ensure inspection...Full timeFlexible hours- ...Indianapolis is looking for a Safety Supervisor to enhance workplace safety. The role involves managing emergency responses, training associates, and ensuring compliance with OSHA regulations associated with our Indianapolis and Plainfield facilities. The ideal candidate...
$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...- ...HR Technology Manager / Workday Lead in Carmel, IN. This role involves leading and optimizing Workday to enhance its value across global business units. The ideal candidate will have experience in Workday HCM, strong facilitation and communication skills, and a bachelor...
$137k - $235.75k
...Job Category: People Leader All Job Posting Locations... ...best talent for the role of Associate Director, Oncology Epidemiology . We... ...date with the FDA and other Regulatory Agencies regarding regulatory... ...Experience working in a global environment is preferred....Full timeTemporary workLocal areaRemote workJohnson & Johnson
Indianapolis, IN6 days ago- Goodwill of Central & Southern Indiana is seeking a Quality Assurance Supervisor located in Indianapolis. This role focuses on overseeing the Quality Management System, ensuring compliance with ISO standards, and providing leadership to QA personnel. The position entails...
$177k - $308k
...to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around... ...enabled drug development while ensuring scientific rigor, regulatory defensibility, and meaningful value creation. Key...Full timeFlexible hours$50k - $55k
...Job Type Full-time Description SkyHop Global is one of the premier ground transportation companies for airline crews.... ...approved budgets. Managing payroll costs daily including weekly submission to Human Resources. Managing fuel costs daily. Minimizes overtime...Full timeLocal areaSkyHop Global
Indianapolis, IN4 days ago- ...Job Description Job Description Description: SkyHop Global is one of the premier ground transportation companies for airline crews... ...budgets. Managing payroll costs daily including weekly submission to Human Resources. Managing fuel costs daily. Minimizes overtime...Local area
Skyhop Global
Indianapolis, INa month ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, Regulatory CMC - Global Submissions Leader. Be the first to apply!
Related searches
- associate manager Carmel, IN
- associate director Carmel, IN
- healthcare team leader Carmel, IN
- clinical team leader Carmel, IN
- application team lead Carmel, IN
- team supervisor Carmel, IN
- team coordinator Carmel, IN
- operational excellence leader Carmel, IN
- team leader Carmel, IN
- recruitment team leader Carmel, IN