- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. **Senior Advisor/ Director , Global Regulatory Affairs - CMC, Small Molecules** At Eli ... to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage CMC technical… more
- Canon USA & Affiliates (Indianapolis, IN)
- …req1193** **OVERVIEW** Responsible for pre-market and post-market activities as assigned by the Director , Regulatory Affairs to include new product planning ... the FDA and CMSU regarding regulatory issues as assigned by the Director , Regulatory Affairs . + Provide guidance to CMSC Business Unit Managers and… more
- Lilly (Indianapolis, IN)
- …tactical, and operational support for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC ... for people around the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control (CMC) scientists to join...need them all over the world. We are seeking Regulatory Scientist GRACMC-Biotechnology to be a part of the… more
- Actalent (Franklin, IN)
- …lines used for orthodontic clients. This position will report directly to the regulatory affairs director . This role involves preparing documentation to ... as tracking documents needed for product registrations within the company's regulatory framework. The position entails participating in inspections and audits… more
- Actalent (Franklin, IN)
- …LOCATED IN FRANKLIN INDIANA Description: This position will report directly to the regulatory affairs director . This role involves preparing documentation to ... as tracking documents needed for product registrations within the company's regulatory framework. The position entails participating in inspections and audits… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose** : The purpose of the Sr. Director role in Global Regulatory Affairs (GRA) - Drug Delivery and ... knowledge, and regulatory expertise and lessons learned across Global Regulatory Affairs to drive internal consistency and influence effective change… more
- Cardinal Health (Indianapolis, IN)
- …capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + Nonclinical ... brand for post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …, Global Regulatory Project Management, GI 2 within our Global Regulatory Affairs organization, based remotely. **_OBJECTIVES/PURPOSE_** + Partners with the ... the pharmaceutical industry and drug development project management and regulatory affairs (eg, clinical development, the prescription...TRAVEL** + Remote within the US + Travel: The Director is expected to come to Quarterly GRA meetings… more
- J&J Family of Companies (Indianapolis, IN)
- …Director , State Policy develops policy positions and partners with US State Affairs colleagues to improve the legislative, regulatory and economic environment ... Director , State Policy - 2406184607W **Description** Johnson &...**Key Responsibilities:** + Applies sophisticated knowledge of the current regulatory and legislative environment and political landscape to advise… more
- Lilly (Indianapolis, IN)
- …operate across many corporate functions including Global Patient Safety (GPS), Global Regulatory Affairs (GRA), Clinical Design, Delivery and Analytics (CDDA), ... in unison to ensure patient safety, data integrity and regulatory compliance. + The Sr Director will establish relationships and partner with other Quality units… more
- Elevance Health (Indianapolis, IN)
- …or fact sheets, as needed; + Reviews regulatory alerts, drafts federal regulatory comments, and ensures Regulatory Affairs and the Mandates organization ... **Health Policy Director ** **Location:** This position will work a hybrid...and develop recommendations and/or solutions. + Partners with Public Affairs and State/Federal Government Affairs areas to… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible...+ Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts… more
- Sumitomo Pharma (Indianapolis, IN)
- …changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + Responsible for compliance with ... **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA)...ensures compliance with GMPs, SMPA procedures and applicable global Regulatory guidelines by providing oversight and management of the… more
- Elevance Health (Indianapolis, IN)
- …state level related to public policy issues covered in the portfolio. + Reviews regulatory alerts and ensures Regulatory Affairs and the Mandates ... **Health Policy Director , Pharmacy Benefit Management** **Location:** This position will...solutions. + Partners with business leaders and State/Federal Government Affairs areas to achieve business goals, including growth initiatives.… more
- Sanofi Group (Indianapolis, IN)
- The **Medical Science Liaison (MSL) Associate Director ** will oversee the effective and efficient functioning of individual MSLs in the region. Ideal candidate will ... : Western Region (West of Chicago) The **MSL Associate Director ** main objectives are to; + Coach, train and...material such as slide decks, in collaboration with Medical Affairs Directors. + Train or advise internal stakeholders. +… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Clinical Nurse Consultant** _The Clinical Nurse Consultant (CNC) ... Associate Director is the leader of a US field-based team...in other regional/field-based positions from the commercial and medical affairs organizations + Promote open dialogue with cross functional… more
- Lilly (Indianapolis, IN)
- …additional items including but not limited to protocols, publications, regulatory interactions, internal executive and governance presentations, external key opinion ... Understand how design elements influence the ability to deliver on new regulatory expectations (eg decentralization of clinical trials, increase racial and ethnic… more
- Sanofi Group (Indianapolis, IN)
- …Medical function serves as a valued strategic partner with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support patients' needs. ... patients. **Job Description:** This position reports to the Senior Medical Director , Respiratory/Allergy. Main job responsibilities: + In partnership with the… more
- CSL Plasma (Indianapolis, IN)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA). **Job Description** + Serves… more
- Lilly (Indianapolis, IN)
- …areas relevant to drug discovery or development, eg epidemiology, toxicology, pharmacovigilance, regulatory affairs + Experience within Global Patient Safety or ... volunteerism. **Purpose:** The purpose of the Medical Device Safety Scientist Associate Director role is to leverage clinical and scientific expertise working across… more