- Formation Bio (New York, NY)
- …mission to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… more
- BeOne Medicines (San Mateo, CA)
- General Description: The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... and registration strategies within the US and Canada. The Director will also provide line management, people development, and...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for...of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and… more
- GRAIL (Boise, ID)
- …GRAIL products with the FDA and/or global health authorities. Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, ... 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 as… more
- GRAIL (Carson City, NV)
- …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
- Cardinal Health (Phoenix, AZ)
- …This role joins a team of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs . Responsibilities: Collaborate ... peers, customers, and suppliers at various management levels Interact with senior management Independently lead Medical Affairs projects Utilizes broad… more
- Endo International (St. Louis, MO)
- …Solving, Building Effective Teams **RELATIONSHIP WITH OTHERS:** Reports to the Sr Director , Quality and Regulatory Affairs . Manages group of exempt ... in our laboratories + Ensure compliance with and oversee compendia affairs for SpecGx **MINIMUM REQUIREMENTS** **:** _Education:_ BS in Chemistry, Chemical… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be responsible ... dashboards to communicate key findings and recommendations to internal stakeholders, including senior leadership and medical affairs teams. Ensure utilization of… more
- Lundbeck (Deerfield, IL)
- Senior Director Medical Affairs , Movement Disorders Requisition ID: 7172 Location Deerfield, IL, US Do you want to join a team where the mission is ... to candidates anywhere in the United States SUMMARY: The Senior Director and Head of Movement Disorders... and Head of Movement Disorders within US Medical Affairs will play a pivotal role reporting to the… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. Clinical Research Medical Sr . Director - Thoracic Oncology What you will do Let's do this. ... patient enrollment in partnership with clinical operations and medical affairs organizations. Support cross-functional and global collaborations to integrate broad… more
- Lundbeck (Deerfield, IL)
- Senior Director Medical Affairs , Movement Disorders Requisition ID: 7172 Location: Deerfield, IL, US Do you want to join a team where the mission is ... to candidates anywhere in the United States** **SUMMARY:** The Senior Director and Head of Movement Disorders... and Head of Movement Disorders within US Medical Affairs will play a pivotal role reporting to the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to the best of my knowledge. Job Description About the role: Join Takeda as the Senior Director , US Medical Affairs - Head of Rheumatology in Cambridge, MA. ... This is a critical role within the US Medical Affairs (USMA) organization that reports to the Vice President...providing coaching/mentorship to team managers, as appropriate. Further, the Senior Director will contribute to the medical… more
- Otsuka America Pharmaceutical Inc. (Olympia, WA)
- …Minimum of 15 years' experience in the pharmaceutical or biotechnology setting within medical affairs strategy Sr Director level medical affairs strategy ... As a senior leader within Medical Affairs , the Executive Director will serve...within a biotech or pharmaceutical setting Expertise in navigating regulatory frameworks and ensuring compliance within medical affairs… more
- Lilly (Lebanon, IN)
- …Process Development, Engineering, Analytical, Quality, Supply Chain and Raw Materials, and Regulatory Affairs . Represent the PTE team during regulatory ... accountability. Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements related to pharmaceutical API/DS manufacturing and tech… more
- Lundbeck (Deerfield, IL)
- Associate Director Medical Affairs - Neurology Requisition ID: 7013 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the ... to candidates anywhere in the greater United States** **SUMMARY:** The Associate Director , Medical Affairs , Neurology serves as the internal scientific expert… more
- Lundbeck (Deerfield, IL)
- …of Rare Epilepsies Evidence Generation within US Medical Affairs will report to the Senior Director and Head of Rare Epilepsies, US Medical Affairs . As a ... Director Medical Affairs , Rare Epilepsies Evidence...Provide medical perspectives to internal stakeholders (Commercial, Market Access, Regulatory , Clinical Development, Pharmacovigilance etc.) ensuring clinical and scientific… more
- Endo International (St. Louis, MO)
- …of 15 years of pharmacuetical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing and control of ... + Minimum 5 years managerial experience in a pharmaceutial quality/ regulatory affairs environment. _Preferred Skills/Qualifications:_ + Previous experience… more
- CSL Behring (King Of Prussia, PA)
- Associate Director , Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Associate Director , Corporate and External Affairs , R&D ... Relationships:** + **Reports to:** Head of Corporate and External Affairs , R&D + **Direct reports to position:** 1 **Main...and partners. + Serve as a key partner to regulatory policy team providing strategic counsel on advocacy opportunities,… more
- CSL Behring (Waltham, MA)
- **Position Title:** Senior Manager, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Senior Manager, Corporate and External Affairs , ... CSL's reputation and policy position. **Reporting Relationships:** **Reports to:** Associate Director , Corporate & External Affairs , R&D Portfolio **Main… more
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