- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... regulatory strategies to ensure effective achievement of regulatory /business objectives. The Executive Director will direct...on the project team throughout the product lifecycle. Provide senior staff advice and guidance on regulatory … more
- Merck & Co. (Upper Gwynedd, PA)
- …- Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/ Sr Principal Scientist in ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Twist BioScience (South San Francisco, CA)
- Sr . Director , Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing ... Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, in-house developed MES solutions across our… more
- Twist BioScience (South San Francisco, CA)
- …leader to lead our global marketing efforts and drive sustainable growth. The Sr Director , Marketing is responsible for leading all aspects of Twist's ... to launching new products; and interfacing with customers. The Sr Director , Marketing also will lead growth...needs of each region - AMER, EMEA and APACFollow regulatory and ISO 13485 requirementsWhat You'll Bring to the… more
- Merck & Co. (Rahway, NJ)
- …data/medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in the development ... mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage… more
- Eisai, Inc (Phoenix, AZ)
- …If this is your profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology ... products within an assigned territory in a compliant and appropriate manner. The Senior Oncology Sales Specialist represents and promotes assigned brand(s) in the IV… more
- Tris Pharma (Monmouth Junction, NJ)
- …Director / Director , Procurement. Title and salary commensurate with experience. The Director / Senior Director , Procurement is responsible for multiple ... and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... development through commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key role in scaling our biologics… more
- Repligen (Waltham, MA)
- …global public company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting ... in accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual filings (eg,… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Merck & Co. (Rahway, NJ)
- …integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director has primary responsibility for the planning ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new...to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …IT, Ethics and Compliance, Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues. Externally, this role ... IT teams to ensure a strong data and technology foundation Engage senior leaders to drive strategic technology transformations Physical Requirements 10-20% overnight… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Genmab (NJ)
- …role will be within Global Regulatory Affairs (GRA) and will report to the Sr . Director , Labeling, Policy and Intelligence. The position may be based in our ... like 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven insights ... and rotations.Demonstrate analytics' value in solving complex business challenges.Engage senior leaders to drive strategic analytics transformations.Partner with Data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, and ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Repligen (Waltham, MA)
- …role will be based in Waltham, MA and will report to the Sr . Director , Quality - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an… more
