- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...Regulatory Affairs (GRA) Process Excellence function, responsible for driving… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs, CMC , New Products, Sales & Marketing, and Legal ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… more
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug Development and/or Late… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC , IP, patient selection, ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound.… more
- EY (New York, NY)
- …Target Screening, Lead Optimization, Vaccines, Lab - Dry & Wet, Instrumentation, LIMS, CMC and other relevant areasStrong Life Sciences R&ED Data Information ... teams and stakeholders.Ensure all clinical trial activities comply with regulatory standards.Prepare comprehensive reports of clinical trial results, and present… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Manager , CMC Regulatory Sciences for Clinical Submissions leads a team that manages the CMC regulatory submission work across multiple ... clinical programs and/or submissions. As a Manager , CMC Regulatory Sciences , a typical day might include the following: + Managing and developing CMC… more
- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Manager for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory ... particular focus on rest of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences , a typical day might include the… more
- Teva Pharmaceuticals (West Chester, PA)
- …for maintaining and updating CMC sections of submissions for assigned products. As Manager CMC Regulatory Affairs you will also be responsible for ... Manager , CMC Regulatory Affairs... Manager , CMC Regulatory Affairs - Remote OR...(MS/PhD in pharmacy, biology, chemistry, pharmacology or related life science , MBA, or MD) + Minimum 7 years of… more
- J&J Family of Companies (Titusville, NJ)
- Manager Global CMC Regulatory Affairs - 2406185933W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Manager , CMC ... expertise to these teams and global regulatory teams. + Ensures that CMC regulatory strategy is aligned with strategies of global regulatory Affairs,… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Commercial Post Approval CMC Regulatory Sciences Associate Manager position responsible for providing Chemistry, ... global regulatory authorities. + Contributing to developing CMC regulatory strategy. This role may be...device, including some supervisory and/or leadership experience. + Associate Manager : Requires 6+ years of relevant experience + … more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Associate Director** **; CMC , Device Development Program Manager ** **Functional Area: Technical Operations** At ... to each other, and trust in ourselves and our science . This is a matrix leadership role that collaborates...collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at our South San Francisco office. As ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...to impact the lives of patients while conducting cutting-edge science . There are short communication lines across the company,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …impact. Join Gilead and help create possible, together. **Job Description** Gilead Sciences , Inc. is a biopharmaceutical company that has pursued and achieved ... 35 countries worldwide, with headquarters in Foster City, California. ** Manager , Global External Manufacturing, Small Molecule Drug Substance** **KEY… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted supply of ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by ... supporting process chemistry and formulation development, and generating data for regulatory submissions. The Principal Scientist will be a technical leader in… more
- Ascendis Pharma (Palo Alto, CA)
- …to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global ... Regulatory Affairs. Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and… more
- Actalent (Maryland Heights, MO)
- …will rely on the Canadian RA staff for country-specific regulations. The Senior Manager Regulatory Affairs will directly participate in project teams managing ... manager is currently managing both the clinical and CMC portions, and they need someone to come in...need experience working with cross functional teams. The Senior Manager of Regulatory Affairs is responsible for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** The Regulatory Data Manager will be a key member of the Global ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...Regulatory Affairs (GRA) Process Excellence function, responsible for driving… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located in our King of ... relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC ) and team… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …review of documents with impact to Analytical Sciences . + Collaborates with CMC Reg Sci to support regulatory filings + Identifies and implements effective ... to join our QC (Quality Control) AS (Analytical Sciences ) team. The Associate Project Manager -...CMC program meetings as a representative of Analytical Sciences to serve as the primary point of contact… more