- Takeda Pharmaceutical (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide.The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... pertaining to prescription medicine promotion.How you will contribute:As our Associate Director , Global Regulatory Affairs Advertising and Promotion… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Insmed Incorporated (San Diego, CA)
- …for each other, 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 ... communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical… more
- Takeda Pharmaceutical (Boston, MA)
- …order to bring life-changing therapies to patients worldwide.The Senior Global Regulatory Affairs , Neuroscience is responsible for developing innovative global ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …health authority regulatory requirements particularly in the areas of Medical Affairs and Clinical Development; Must have a strong understanding of ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director..., representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory … more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible for supporting the ... Affairs strategic vision. This position will report directly to the Executive Director of Medical Affairs . Together with the Executive Director of… more
- Insmed Incorporated (NJ)
- … regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with ... Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve... CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function,… more
- Merck & Co. (Rahway, NJ)
- …and execution globally across Global Regulatory Affairs CMC (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), ... This individual will be a senior member of the Regulatory Affairs CMC organization and will also...modality or traditional solid-oral small molecules and includes pre-approval regulatory strategy and submissions (global clinical and… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and… more
- Takeda Pharmaceutical (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide.Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible ... among functions represented at the Labeling cross functional teams, including clinical , safety, medical affairs , and commercial, to ensure unparalleled… more
- Tris Pharma (Monmouth Junction, NJ)
- …closely with clinical leaders, statisticians, bioanalytical teams, and regulatory affairs to inform key development decisions.Designs non- clinical ... and team success.We have an opening in our Monmouth Junction, NJ Facility for a Director , Clinical Pharmacology. The Director , Clinical Pharmacology is… more
- Takeda Pharmaceutical (Boston, MA)
- …inspire you and empower you to shine? Join us as a Executive Medical Director , Oncology Clinical Sciences in our Cambridge office.At Takeda, we are transforming ... Development Plan (IGDP). Responsible for review of synopses, other relevant clinical study documents and Critical Study Results. Provide leadership and oversight… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …target product profile (TPP) development, due diligence projects, and clinical - regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities ... clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study protocols,… more
- Eisai, Inc (Nutley, NJ)
- … Senior management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical ... international regulatory /ethical guidelines relevant to the pharmaceutical industry & clinical trial conduct, and to ensure compliance with these external as… more
- Insmed Incorporated (NJ)
- …data.Supports research and development programs as requested by Insmed R&D, Clinical Development & Operations, and Medical Affairs Departments.Partners with ... Insmed departments and functions. Further proactive communication with Commercial, other Medical Affairs functions, Clinical and business partners as it relates… more
- Insmed Incorporated (NJ)
- …engage PAH specialists, community physicians, and allied healthcare providers.Partner with Medical Affairs to ensure scientific and clinical insights inform HCP ... Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial… more
- Insmed Incorporated (NJ)
- …QC content for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC ... or practices from external labs.Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs , Supply Chain, and other departments to ensure… more
- Insmed Incorporated (San Diego, CA)
- …will collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.What ... technical expertise and system documentation.Ensure data integrity, system reliability, and regulatory compliance across all phases of clinical development.Team… more
- Insmed Incorporated (NJ)
- …and go-to-market frameworks tailored to dermatologists treating HS.Partner with Medical Affairs and Commercial Effectiveness to ensure key clinical and ... of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our brensocatib...Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy,… more
- Merck & Co. (North Wales, PA)
- …experienced, motivated, and passionate commercial talent to serve as the Executive Director , US Commercial Leader, for our Ulcerative Colitis Indication within our ... Collaborate with key stakeholders across the enterprise, including Medical Affairs , Manufacturing, Global Marketing, Global digital data and analytics, PDT/Research… more
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