- 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 ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… 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 ... RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of Regulatory … more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for reviewing the ... CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders to formulate regulatory strategies for… more
- Takeda Pharmaceutical (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide.The Associate Director Global Regulatory Affairs , Neuroscience is responsible for ... appropriate regulatory strategy. Participates in cross-functional initiatives within Global Regulatory Affairs and Takeda R&D. How you will contribute: The… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in ... candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well… more
- Takeda Pharmaceutical (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... 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)
- …areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs ... , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory ...and working toward building a quality mindset with Medical Affairs .Support the Sr. Director 's Medical Affairs… 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
- 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 ... of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a healthcare industry required- 4 or More… more
- Merck & Co. (Rahway, NJ)
- …we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also manage significant cross-modality ... dedicated colleagues while developing and expanding your career.The Executive Director , Chemistry, Manufacturing & Controls ( CMC) , Pre-approval...projects as an extension of the overall Regulatory Affairs CMC Leadership Team.-This Lead plays… 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 ... and assures that Takeda labeling content and processes conform to regulatory requirements.Management of Local Exceptions and LOC InteractionsManages process for… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director / Director , MSLs is responsible for the leadership, direction and management of MSLs ... in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively with Medical … more
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... 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 Hypertension… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The National Senior Director , US Field Medical is responsible for the direct leadership of the Chronic ... responsibilities, and initiatives for respective therapeutic area. The National Director will provide significant input into designing, developing, and implementing… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … 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
- Tris Pharma (Monmouth Junction, NJ)
- …collaborate closely with clinical leaders, statisticians, bioanalytical teams, and regulatory affairs to inform key development decisions.Designs non-clinical ... success.We have an opening in our Monmouth Junction, NJ Facility for a Director , Clinical Pharmacology. The Director , Clinical Pharmacology is responsible for… more
- Insmed Incorporated (NJ)
- …Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial ... 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
- 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
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
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