- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional ... (fast track, RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of … more
- BeOne Medicines (Emeryville, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … more
- Parexel (Concord, NH)
- **Join Parexel as a Regulatory Affairs Strategy Lead** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... plans? If so, we'd love to connect. We're seeking Regulatory Affairs Strategy Leads who will be...biologics - Deep knowledge of FDA, ICH, and global regulatory frameworks - Experience with international clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory requirements and ... for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in...regulatory requirements particularly in the areas of Medical Affairs and Clinical Development; Must have a strong understanding… more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity** As the Senior Director, Medical Affairs , you will lead the development and execution of Medical Affairs strategies and tactics to support ... leaders in relevant fields + Review and approve medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs , and Commercial +… more
- CSL Behring (King Of Prussia, PA)
- …of 6 years of experience in the life sciences industry, with exposure to regulatory affairs or a related function. -Strong analytical, data interpretation, and ... to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager, Regulatory Science? The job is in our King of Prussia,… more
- Merck & Co. (North Wales, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... each other, and for the future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our TPIP program in Pulmonary Arterial… more
- Insmed Incorporated (NJ)
- …Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial ... other, and for the future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our brensocatib program in HS (hidradenitis… more
- Caris Life Sciences (Irving, TX)
- …Oncology, with deep experience in malignant hematology, to join our dynamic Medical Affairs team as ** Senior Medical Director** . This individual will serve ... as a key strategic leader, reporting to the Senior Vice President of Medical Affairs and Chair of the Precision Oncology Alliance (POA). The Senior Medical… more
- Lundbeck (Deerfield, IL)
- …in development by providing substantive advice to US operations, including Marketing, Medical Affairs and Regulatory Affairs departments, concerning a broad ... Senior Counsel Requisition ID: 6856 Location: Deerfield, IL,...handling a variety of substantive legal issues, providing legal, regulatory and compliance counsel to Lundbeck's US rapidly growing… more
- BeOne Medicines (San Mateo, CA)
- …teams for PV matters + Support Business Owners functions, such as Medical Affairs , Commercial, or Marketing in the development of processes, forms, and/or training ... and guidance documents for the Programs to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices + Look for… more
- FM (Johnston, RI)
- … Counsel, the Manager, Corporate Affairs , and other Law & Governmental Affairs colleagues as needed, with recommendations to senior management and internal ... combining property loss prevention with insurance protection. **Summary** The Corporate Affairs Contracts Specialist II role is responsible for providing global… more
- DHL Express, Inc. (Plantation, FL)
- …the VP of Customs and Regulatory Affairs and the leaders of: Regulatory Affairs , International Trade Affairs Legal, Customs Compliance, Security ... improve our services. + Trade Knowledge Support: Review, interpret (in conjunction with regulatory affairs and knowledge support, whether regional or local, or… more
- Eisai, Inc (Memphis, TN)
- …of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively ... with Medical Affairs and Clinical Development teams for support of clinical...of the FDA, OIG, HIPPA, PhRMA, GCP and other international regulatory /ethical guidelines relevant to the pharmaceutical… more
- Merck & Co. (Upper Gwynedd, PA)
- …position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research.Under the guidance of a senior ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates and may… more
- Parexel (Des Moines, IA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is fully informed and ... readiness as well as preparing for, management and follow up of regulatory inspections. **Primary Duties:** Operational Quality Management: + Develop Risk Assessment… more
- Hawaiian Electric (Honolulu, HI)
- …Electric Companies, including in operations, engineering, planning, community relations, and regulatory affairs . + Evaluates and selects large complex or ... entities for each service territory. Serves as the expert advisor to senior management on energy, capacity, storage, and non-wire alternative procurement issues,… more
- J&J Family of Companies (Santa Clara, CA)
- …pressure waves for the treatment of calcified plaque. The ** Senior Director, International Regulatory Affairs ** , works closely and partners with ... to meet regulatory requirements. In alignment with Regulatory Affairs senior management, functions...is preferred + Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations +… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- **Job Description Summary** We are seeking a Senior International Regulatory Affairs Specialist to join our Regulatory Affairs team. This role is ... a maker of possible with us. **Position Summary:** We are seeking a Sr. International Regulatory Affairs Specialist to join our Regulatory Affairs … more
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