- GRAIL (Indianapolis, IN)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Parexel (Indianapolis, IN)
- …FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate , you will serve as the ... and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of… more
- Sumitomo Pharma (Indianapolis, IN)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Lilly (Indianapolis, IN)
- …the business. RLT also provides regulatory law advice to Global Regulatory Affairs , Manufacturing & Quality, Global Patient Safety, Clinical Development and ... around the world. **Organization Overview:** This position will be part of the Regulatory Legal Team (RLT), which reports up through Lilly's General Counsel and… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Associate Director, Scientific Communications manages the execution of...consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. **Key Responsibilities Include:**… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Lilly (Indianapolis, IN)
- …processes and product quality. * Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory Affairs , and Supply Chain teams to ensure seamless ... Lilly and Company is seeking an experienced and highly motivated Associate Director to join our Technical Services/Manufacturing Science (TS/MS) team, specializing… more
- Lilly (Indianapolis, IN)
- …methods. + Collaborate cross-functionally with internal teams (eg, Supply Chain, Regulatory Affairs , Technical Services) and external manufacturing partners to ... Biochemistry, Pharmacy, Chemical Engineering) or related field. + Minimum of 5-8 years ( Senior Associate ) or 8+ years (Principal Associate ) of experience… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …a technical leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality ... **Job Summary** The Associate Director, Quality Operations will lead initiatives that...on key risk indicators and escalate critical risks to senior leadership. **Global Quality System Processes** + Oversee the… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- Newell Brands (Indianapolis, IN)
- …a related field. + 3-5 years of experience in tax incentives, government programs, regulatory affairs , or a related area (internships or co-op experience may be ... and collaborative environment where you can be your best, every day. The Associate Manager, Tax Incentives & Grants will support the Manager in identifying,… more
