- Sumitomo Pharma (Indianapolis, IN)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs ** . The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… 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
- Takeda Pharmaceuticals (Indianapolis, IN)
- …application is true to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for ensuring that ... pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and external CRO… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices 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 GRA-CMC to be a part of the… more
- Lilly (Indianapolis, IN)
- …from an accredited college or university + At least 5 years of regulatory affairs experience with research-based drug development, including early phase (first ... Ph1/Ph2) submission experience. + Demonstrated understanding of clinical drug development and regulatory affairs , including regulations in the US, UK, EU, and… more
- Sumitomo Pharma (Indianapolis, IN)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... member of the Medical Affairs team reporting to the Executive Director ,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Sumitomo Pharma (Indianapolis, IN)
- …Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... company programs and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains professional relationships with… more
- Sumitomo Pharma (Indianapolis, IN)
- …, Medical Strategy (Women's Health) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... leadership and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties and Responsibilities**… more
- Sumitomo Pharma (Indianapolis, IN)
- …. **Job Overview** Director , Field Medical and ... summarizes, and disseminates key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner. + Participate in the… more
- Lilly (Indianapolis, IN)
- …journey " and the strategic plan for the compound ), medical support for regulatory affairs and interactions with government agencies (medical support for New ... position is $252,000 - $369,600 Clinical Research Physician - Medical Affairs , Neuroscience Business Unit, Psychiatry Purpose: Through the application of scientific… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management… more
- United Therapeutics (Indianapolis, IN)
- …primarily responsible for providing expert legal support to Marketing, Sales, Medical Affairs , Patient Relations, Regulatory Affairs and Corporate ... Company's various products. + Provide guidance to Sales, Marketing, Medical Affairs , Patient Relations, Regulatory and Corporate Compliance departments related… more
- Sumitomo Pharma (Indianapolis, IN)
- …. **Job Overview** The **Executive Director Head of Medical Strategy** will ... be a key member of the Medical Affairs Leadership team reporting to the Vice President,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Lilly (Indianapolis, IN)
- …- $220,000 **Position Responsibilities** : The Lilly Neuroscience Communications Sr. Director will be responsible for driving the internal and external ... for the neuroscience pipeline and portfolio - including scientific data, regulatory achievements, and disease state education campaigns 2. integrated communications… more
- Lilly (Indianapolis, IN)
- …and Access Programs is accountable for partnering with drug development teams, Global Regulatory Affairs (GRA), Clinical, CM&C, and the broader Product Delivery ... areas: pharmacy, drug development, clinical drug development, CT material, CM&C, global regulatory affairs , quality, or commercial manufacturing + Licenses or… more
- Lilly (Indianapolis, IN)
- …EMA) and Good Clinical Practice (GCP) guidelines. + Collaborate with Technical Teams, Regulatory Affairs , and other departments to resolve quality issues and ... This role ensures that clinical trial material is prepared in compliance with regulatory requirements and company standards. The Sr. Director QA collaborates… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the development ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… 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
- 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