- Cytokinetics (South San Francisco, CA)
- …function and contractility. Job purpose Cytokinetics is seeking an experienced and highly motivated Senior Director , Regulatory Affairs to join the Global ... Regulatory Affairs team. The Senior Director will be responsible for developing, implementing and advising on global regulatory strategies for clinical… more
- Eli Lilly and Company (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing...oral products will use CMC technical knowledge and regulatory science expertise to drive regulatory CMC… 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
- Central Garden & Pet (Dallas, TX)
- …application of department procedures/policies, etc.; and, other duties as required/requested by the Senior Director , FDA Regulatory Affairs & Food Safety ... (FSRA) Manager to join our team! This position reports to the Sr. Director , FDA Regulatory Affairs & Food Safety and will support all applicable Central animal… more
- 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
- 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
- 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
- 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
- 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
- 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)
- …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
- 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
- Crdit Agricole CIB (New York, NY)
- …/ Financial Security Job title Head of Investment and Corporate Banking Regulatory Compliance ("ICBRC") Americas - Director Contract type Permanent Contract ... Side and Investment Research activities. The role requires strategic leadership, regulatory expertise, and collaboration with senior business and compliance… more
- Revolution Medicines (Redwood City, CA)
- …harboring mutations in the RAS signaling pathway. The Opportunity: The Associate Director of Regulatory Affairs will independently represent regulatory ... senior concerning risks. Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence. Help drive operational… 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
- Metropolitan Transportation Authority (New York, NY)
- Description Position at MTA Headquarters POSTING NO. 11765 JOB TITLE: Senior Deputy Director , Tenant Management DEPT/DIV: Real Estate, Tenant Management WORK ... reliable commute, excellent customer service, and rewarding opportunities. Position Objective: The Senior Deputy Director of Tenant Management will serve as a… more
- Seaton Towson (Towson, MD)
- …Discovery Management Group Discovery Management Group is part of the Discovery Senior Living family of companies, a recognized industry leader for performance, ... and lifestyle customization that today, ranks among the 2 largest US senior living operators. Discovery Management Group specializes in managing and enhancing … more
- AstraZeneca (Gaithersburg, MD)
- Senior Director , Drug Product and Packaging Tech Transfer Location: Gaithersburg Be a Catalyst for Change at AstraZeneca Are you ready to lead with purpose and ... drive innovation that makes a global impact? Join AstraZeneca as our Senior Director , Drug Product and Packaging Tech Transfer , and play a vital role in… more
- FinTrust Connect LLC (Elmwood Park, NJ)
- About the job VP Assistant Director Senior Portfolio Manager VP, Assistant Director Senior Portfolio Manager -Bergen County, NJ FinTrust Connect is ... our partnership with a well-established commercial lender seeking a VP, Assistant Director Senior Portfolio Manager to join their credit leadership team.… more
- nChroma Bio (Boston, MA)
- …and breakthrough medicines. ABOUT THE ROLE nChroma Bio is seeking a Senior Director , Analytical Development/Quality Control to drive the strategic development ... related to QC. The candidate's ability to represent the AD/QC function in Regulatory CMC meetings and drafting the Module 3/IB documents is a must. Candidate… more
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