NewRegulatory Affairs Manager BC Forward AsymblRegulatory Affairs ManagerIndianapolis, Indiana$45–$50 / hourFull timeThe ideal candidate will have strong experience in global regulatory submissions, IVDs/medical devices/biopharma regulations, and regulatory change control and a proven ability to secure and maintain product approvals across multiple regions while driving cross-functional alignment and timely registration outcomes . With delivery centers and offices across North America and India, we take pride in building long-term relationships and delivering excellence through innovation, collaboration, and integrity.
Director MISO Regulatory Affairs American Municipal Power, IncDirector MISO Regulatory AffairsCarmel, INFull timeMust possess excellent communication, presentation, diplomacy, active listening, and facilitation skills to effectively work in small or large group forums ranging from technical to non-technical audiences at all levels of the corporate hierarchy. Preferred to have knowledge of capacity, energy, ancillary services market rules, market settlements, applicable FERC orders, applicable MISO and NAESB rules, and emerging generation and transmission technologies.
NewRegulatory Affairs Manager I_CO - Contract TalentBurst, Inc.Regulatory Affairs Manager I_CO - ContractIndianapolis, IN$50–$53 / hourThe efficiency and the success of the Regulatory activities and strategies are maintained by clear agreements with other functions, stakeholders and external partners (authorities, companies, NBs etc). Contributes to or leads projects with an understanding of how business functions, systems, processes, and data management are connected and essential to achieving digitalization and strategic goals.
NewRegulatory Affairs Manager CYNET SYSTEMSRegulatory Affairs ManagerIndianapolis, IN$48–$53 / hourTemporaryContractorPart timeAs a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. 3-5 years of experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs, Medical devices, Pharma, or Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
NewFamily Nurse Practitioner/Physician Assistant - Up to $5K Sign On Bonus Fast Pace HealthFamily Nurse Practitioner/Physician Assistant - Up to $5K Sign On BonusGreenfield, INPosting Title: Family Nurse Practitioner/Physician Assistant - Up to $5K Sign On Bonus Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy Eli Lilly and CompanySenior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory StrategyUs, Indiana$169,500–$248,600 / yearOur current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL). Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.
Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine Eli Lilly and CompanyGlobal Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/VaccineUs, Indiana$169,500–$248,600 / yearOur current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL). Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.
Regulatory Affairs Project Manager RocheRegulatory Affairs Project ManagerIndianapolis, IndianaIn this position, you will have an administrative role in registering and addressing affiliate questions for a wide array of innovative medical diagnostic products for researchers, physicians, patients, hospitals, laboratories and blood banks in high profile demographic regions, specifically in APAC, LATAM, Middle East and Africa. Assist in submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.
Regulatory Affairs Project Manager F. Hoffmann-La Roche LtdRegulatory Affairs Project ManagerIndianapolis, IN$93,000–$172,900 / yearIn this position, you will have an administrative role in registering and addressing affiliate questions for a wide array of innovative medical diagnostic products for researchers, physicians, patients, hospitals, laboratories and blood banks in high profile demographic regions, specifically in APAC, LATAM, Middle East and Africa. Assist in submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.
Associate Director, Regulatory Affairs - Biologics Elanco Animal Health IncAssociate Director, Regulatory Affairs - BiologicsIndianapolis, INElanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees. The ideal candidate brings experience in biologics, vaccines, biotechnology, or pharmaceutical regulatory affairs and has supported regulatory strategy, health authority interactions, and regulatory submissions.
Director, Product Compliance And Regulatory Affairs Delta Faucet CompanyDirector, Product Compliance And Regulatory AffairsIndianapolis, IN$121,300–$190,630 / yearE-Verify is an Internet based system operated by the Department of Homeland Security (DHS) in partnership with the Social Security Administration (SSA) that allows participating employers to electronically verify the employment eligibility of their newly hired employees in the United States. Collaborate with Engineering, Quality, Product, Sourcing, Legal, Manufacturing, and other collaborators to identify, assess, and mitigate product compliance risks in new product launches, engineering changes, systems, and business processes.
Director, Product Compliance and Regulatory Affairs Delta Faucet CoDirector, Product Compliance and Regulatory AffairsIndianapolis, IN$121,300–$190,630 / yearE-Verify is an Internet based system operated by the Department of Homeland Security (DHS) in partnership with the Social Security Administration (SSA) that allows participating employers to electronically verify the employment eligibility of their newly hired employees in the United States. Collaborate with Engineering, Quality, Product, Sourcing, Legal, Manufacturing, and other collaborators to identify, assess, and mitigate product compliance risks in new product launches, engineering changes, systems, and business processes.
NewRegulatory Affairs Manager I Integrated Resources, IncRegulatory Affairs Manager IIndianapolis, IN3-5 years experience with PhD degree, 5-7 with master s degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent. Proactively creates unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
NewUS_Regulatory Affairs Manager I_CO The Fountain Group LLCUS_Regulatory Affairs Manager I_COIndianapolis, INLead regulatory activities for products within assigned areas, supporting product registrations and regulatory approvals across global markets. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners.
Director, Product Compliance and Regulatory Affairs Masco CorpDirector, Product Compliance and Regulatory AffairsIndianapolis, IN$121,300–$190,630 / yearE-Verify is an Internet based system operated by the Department of Homeland Security (DHS) in partnership with the Social Security Administration (SSA) that allows participating employers to electronically verify the employment eligibility of their newly hired employees in the United States. Collaborate with Engineering, Quality, Product, Sourcing, Legal, Manufacturing, and other collaborators to identify, assess, and mitigate product compliance risks in new product launches, engineering changes, systems, and business processes.
Director, Product Compliance And Regulatory Affairs Masco Corp.Director, Product Compliance And Regulatory AffairsIndianapolis, IN$121,300–$190,630 / yearE-Verify is an Internet based system operated by the Department of Homeland Security (DHS) in partnership with the Social Security Administration (SSA) that allows participating employers to electronically verify the employment eligibility of their newly hired employees in the United States. Collaborate with Engineering, Quality, Product, Sourcing, Legal, Manufacturing, and other collaborators to identify, assess, and mitigate product compliance risks in new product launches, engineering changes, systems, and business processes.
SubChapter Lead Regulatory Affairs - Lab Coagulation and Clinical Chemistry RocheSubChapter Lead Regulatory Affairs - Lab Coagulation and Clinical ChemistryIndianapolis, IndianaYou nurture and develop an empowered, knowledgeable, effective and efficient group of subject matter experts (SMEs) within the subchapter with the capabilities to support Roche Diagnostics’ efforts with best-in-class expertise. As a Lab Coagulation and Clinical Chemistry II Subchapter lead in the Medical Value Assays Chapter, you will be a member of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT).
SubChapter Lead Regulatory Affairs - Endocrinology and Fertility RocheSubChapter Lead Regulatory Affairs - Endocrinology and FertilityIndianapolis, IndianaYou nurture and develop an empowered, knowledgeable, effective and efficient group of subject matter experts (SMEs) within the subchapter with the capabilities to support Roche Diagnostics’ efforts with best-in-class expertise. You enable the organization’s New Ways of Working by acting as Role-model for Agile Leadership behaviors, as well as for our culture, and mindset as defined in We@RocheDiagnostics.
SubChapter Lead Regulatory Affairs - Lab Coagulation and Clinical Chemistry F. Hoffmann-La Roche LtdSubChapter Lead Regulatory Affairs - Lab Coagulation and Clinical ChemistryIndianapolis, IN$111,200–$258,700 / yearYou nurture and develop an empowered, knowledgeable, effective and efficient group of subject matter experts (SMEs) within the subchapter with the capabilities to support Roche Diagnostics' efforts with best-in-class expertise. As a Lab Coagulation and Clinical Chemistry II Subchapter lead in the Medical Value Assays Chapter, you will be a member of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT).
SubChapter Lead Regulatory Affairs - Endocrinology and Fertility F. Hoffmann-La Roche LtdSubChapter Lead Regulatory Affairs - Endocrinology and FertilityIndianapolis, IN$111,200–$258,700 / yearYou nurture and develop an empowered, knowledgeable, effective and efficient group of subject matter experts (SMEs) within the subchapter with the capabilities to support Roche Diagnostics' efforts with best-in-class expertise. You enable the organization's New Ways of Working by acting as Role-model for Agile Leadership behaviors, as well as for our culture, and mindset as defined in We@RocheDiagnostics.