- Medtronic (Irvine, CA)
- …for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. ... that our product technical documentation is current and accurate. SENIOR REGULATORY AFFAIRS SPECIALIST -...EU regulatory requirements and partners with the international regulatory affairs group to… more
- Fate Therapeutics, Inc. (San Diego, CA)
- Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and execution of ... located at our corporate headquarters in San Diego, CA. Responsibilities Lead the Regulatory Affairs team in effectively working with internal and external… more
- Stryker (Mahwah, NJ)
- …three days per week in Mahwah, NJ or Weston, FL. What you will do As the Senior Regulatory Affairs Specialist , you will support Stryker's Mako and Enabling ... Work Flexibility: Hybrid We are seeking a Senior Regulatory Specialist to join our...years of experience in medical device regulatory affairs Thorough understanding of FDA, Europe, and international… more
- Lexington Medical (Bedford, MA)
- …of millions of patients worldwide and thrive in a growing company. We are seeking a Senior Regulatory Affairs Specialist to develop, lead and execute a ... product approvals and clearances. Qualifications: Bachelor's degree in Science, Engineering, Regulatory Affairs , or other technically related field. 5-8+ years… more
- BioSpace (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 ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Cleerly (Denver, CO)
- …be listed as requirements in the job description. About the Opportunity As Principal Regulatory Affairs Specialist, you will provide regulatory support and ... and regulatory compliance issues. Mentorship & Development: Mentor and develop senior regulatory professionals, guiding them through complex regulatory … more
- Betco Corporation, LTD (Bowling Green, OH)
- …development and present findings. Monitor, analyze, interpret and present information to senior management concerning regulatory affairs related to current ... Develop, implement and coordinate compliance with federal, state, local and international regulatory requirements applicable to Institution cleaning chemicals,… more
- Omnicom Health (New York, NY)
- …a unique model of four powerhouses- Commercial & Marketing, Medical Affairs , Publications, Regulatory - that enables hyperconnected, audience-centric engagement ... patients. Together, we accelerate the impact of science. Associate Scientific Director ( Regulatory ) We are seeking a seasoned Associate Scientific Director with a… more
- BioPharma Consulting JAD Group (Cambridge, MA)
- …authority inspections. Experience working with PSMF and familiarity with medical affairs and regulatory requirements. Strong collaboration and communication ... The Senior Manager, Global Pharmacovigilance (PV) Quality Assurance is...Good Pharmacovigilance Practices (GVP) Modules, FDA regulations, and other international PV requirements. The role will also support the… more
- NSF (Ann Arbor, MI)
- …relationships with key specifiers, retailers, influencers, clients, industry stakeholders, and regulatory bodies Work with Standards and Government Affairs to ... Job Description The Senior Director for NSF's Nutrition and Wellness business...record in P&L management and driving business growth Extensive international experience in leading and growing a global business… more
- Dexcom, Inc. (San Diego, CA)
- …interfaces. (Internal examples: Supplier Quality, Quality, Engineering, Manufacturing, Regulatory Affairs , Receiving Inspection. External examples: Suppliers). ... health on a global scale stands before us. Meet the team: The Senior level Supplier Quality Engineer engages suppliers in three fundamental means: Supplier… more
- Eisai, Inc (Nutley, NJ)
- …of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include ... interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and other internal medical… more
- Eli Lilly and Company (Indianapolis, IN)
- …and relevant clinical experience, the Diabetes and Obesity Business Unit - Global Medical Affairs Senior /Executive Director is an integral member of the medical ... of the Diabetes and Obesity Business Unit - Medical Affairs Senior /Executive Director is to provide expert...the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Merck & Co. (North Wales, PA)
- …resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research, and will support Pneumococcal Vaccines.Under the ... guidance of a senior leader, this position supports value evidence outcomes research...is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates and… more
- Abbott (Santa Clara, CA)
- …practice. Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interacts with ... deliverables. Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG),… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... develops value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research… more
- Temple School Of Medicine (Philadelphia, PA)
- …development among departmental staff. *Work with the Department Vice Chair of Academic Affairs , Department Chair, and Senior Associate Dean, Office of Faculty ... efficient allocation and compliance with institutional financial goals. *Provide senior clinical leadership for the Nephrology/Kidney Transplant Section, fostering a… more
- Elanco Animal Health Incorporated (Indianapolis, IN)
- …in global, cross-functional project teams (eg, clinical, pharmaceutical development, regulatory affairs , quality, manufacturing) within a matrix organization ... life better - join our team today! Your Role: Senior Research Scientist, Non-Clinical Safety & Toxicology We are...(eg, PDEs, OELs), and target safety assessments. Engage with regulatory agencies to address safety concerns for both products… more
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