- Sumitomo Pharma (Indianapolis, IN)
- …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...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Sumitomo Pharma (Indianapolis, IN)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and...will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC… more
- Lilly (Indianapolis, IN)
- …over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC technical ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing...knowledge and regulatory science expertise to drive regulatory CMC… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructively challenge teams to reach… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs , Global Regulatory Lead (GRL) ... behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in forums that share regulatory … more
- Cardinal Health (Indianapolis, IN)
- …joins a team of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs . **Responsibilities:** + Collaborate across ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- Lilly (Indianapolis, IN)
- …"patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for ... clinical experience, the Cardiovascular/Cardiometabolic Business Unit - Global Medical Affairs Clinical Research Physician (CRP) Senior/Executive Director is… more
- Comcast (Indianapolis, IN)
- …in all levels of government. + Assist in coordination with HQ Shared Services Regulatory Affairs , Franchising on all franchising activity. + Assist with the ... **Job Summary** Reporting to the Senior Vice President, Government & Community Affairs ("GCA"), District 3, this role leads local governmental policy and advocacy… more
- Lilly (Indianapolis, IN)
- …with internal business partners including clinical teams, commercial teams, legal, regulatory affairs , ethics and compliance, and other relevant functions. ... make life better for people around the world. The Senior Director of Gene Therapy Medical Affairs will work across our gene therapy portfolio in multiple… more
- Roche (Indianapolis, IN)
- …marketing, medical affairs , legal, and other business stakeholders. The Regulatory Compliance Director may contribute to global cross-functional or ... Join Roche, where every voice matters. **The Position** **The Opportunity** The Regulatory Compliance Director is a people leader role. Primary responsibilities… more
- Lilly (Indianapolis, IN)
- …disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs . **Additional Skills/Preferences:** + Responsible for ... better for people around the world. #WeAreLilly **Responsibilities:** The Associate Director - Quality Assurance (QA) API External Manufacturing is responsible for… more
- Lilly (Indianapolis, IN)
- …+ Experience in Manufacturing, QC, QA, Technical Services, Engineering or Regulatory Affairs . + Excellent interpersonal skills and networking skills. ... life better for people around the world. #WeAreLilly **Responsibilities:** The Associate Director - Quality Assurance (QA) is responsible for managing the activities… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …, legal, and ethical guidelines + Foster strong partnerships with Medical Affairs , Clinical Development, Market Access, Market Research, Regulatory , Legal, and ... our focus to ultra-rare neurological conditions. **Job Summary** The Executive Director , Sales and Marketing, Neurology Rare Disease will be responsible for… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... **Associate Director , Small Molecule Analytical Development** + Lead and...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Position Summary:** The Director GVE Operations oversee and coordinates projects within the department to ensure alignment with organizational goals. This role is ... other integrated data generation initiatives. This position reports to the Senior Director , Global Integrated Evidence & Innovation Operations and can be based in… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Role Overview** The Sr. Director , Clinical Development is an experienced clinical trialist who will be responsible ... into clinical development programs both externally and internally (eg, Medical Affairs , Commercial, CROs, etc.). They will provide clinical / scientific support… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Position Summary** The Director , HCP Marketing Lead guides the healthcare provider (HCP) engagement strategy for Centanafadine, a novel launch product for ADHD. ... engagement to drive awareness, adoption, and utilization among HCPs. The Director will work cross-functionally with sales, market access, medical affairs… more
- Lilly (Indianapolis, IN)
- …teams, including medicinal chemistry/genetic medicines/bioproducts, toxicology/ADME, bioinformatics, and regulatory affairs , to integrate data and drive ... opinion leaders, and potential partners. + Contribute pharmacology data to regulatory filings, including Investigational New Drug (IND) submissions. + Support… more
- Lilly (Indianapolis, IN)
- …-Teamwork and interpersonal skills -5 years' experience in Quality and/or Regulatory Affairs Additional Preferences: -Auditor certification (ASQ CQA) and/or ... Associate QA-IDM (Auditor) will report to the Quality Associate Director and will have responsibility for assessing PDS functional... Regulatory Affairs Certification (RAC, RAPS) -Experience with Microsoft Applications, SAP,… more