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Assists in Corporate Security and Regulatory Affairs (CSRA) training program development and training presentations related to DCP, OMP and general pharmacy operations. Also, under the general direction of the Senior Director of Corporate Security and Regulatory Affairs (Specialty), responsible for assisting in compliance and regulatory matters of Cencora's internal pharmacy and reimbursement operations.
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The position requires collaboration with other state and US government affairs team members and 3M’s government affairs team globally, as well as the company’s regulatory, legal, compliance teams as well as business and operations executives to help develop and advocate for the company’s positions on state public policy matters.
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissions.
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Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 clinical programs meet the needs of local/regional customers.
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Partner with stakeholders across research, clinical operations, regulatory affairs, and Tech@Lilly to ensure alignment on vision and execution. Familiarity with the regulatory landscape of clinical trials and data privacy standards.
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In this role, you will provide hands-on, day-to-day technical and strategic leadership and work closely with cross functional teams in Analytical Development, Process Development, Global Quality and Regulatory Affairs-CMC, and our partners in in the commercial/manufacturing to support commercialization of our company's large molecule products.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Effectively interact with staff in R&D, QA, QC, Regulatory Affairs and Clinical departments. Knowledge of immunoassay chemistries, PCR methods, IVD product development and manufacturing processes, and equipment validations.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Kimball Medical Solutions is a Medical Device Contract Manufacturer in Indianapolis, IN and the this position will report to the Quality and Regulatory Affairs Manager and have specific responsibility for a customer or several customers.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Stays up to date with knowledge of regulatory affairs and/or issues, including IRB, radiation safety, and Good Clinical Practices. Performs quantitative imaging outcomes for bone health and body composition using dual-energy x-ray absorptiometry and high-resolution peripheral quantitative computed tomography.
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They are experts in financial structuring, engineering, construction management, and regulatory affairs, Overall, they lead the industry in comprehensive energy solutions. Comprehensive knowledge of regulatory requirements and permitting processes in renewable energy.
$130,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Masters Degree in Environmental Science or Public Affairs and/or 2+ years experience in a water resource-related field. Commonwealth Engineers seeks an experienced Regulatory Compliance Specialist to join our award-winning engineering design and consulting firm.
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You'll advise clients on their local and overseas tax affairs, while acting as a strategic consultant related to business analysis, managing indirect taxes, dispute resolution, and global enterprise tax solutions.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Work with cross-functional teams, including Process Development, Quality Assurance, Regulatory Affairs, and Supply Chain, to ensure alignment with regulatory requirements and company standards.
$130,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Proven experience in compliance, regulatory affairs, internal audit, legal or operations role, or a combination of these roles within the financial services industry. If you need an accommodation during the application process due to a disability, please send an email to: EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person.
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Experience in quality assurance, quality control, or regulatory affairs within thepharmaceutical manufacturing industry. Vikram J |Talent Acquisition Specialist | IT Minds LLC | Strong understanding of pharmaceutical manufacturing processes and quality systems.
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regulatory affairs jobs in Indianapolis, Chagrin-falls, Ohio
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