- Tris Pharma (Monmouth Junction, NJ)
- …globally. We have an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ... This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs, CMC , New Products, Sales & Marketing, and Legal… more
- Merck & Co. (North Wales, PA)
- …in the Research & Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug ... integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas)… more
- Novo Nordisk Inc. (Boulder, CO)
- …GMP manufacturing experience in the areas of biotechnology/pharmaceuticals. Relationships Senior Manager , Material Management. Essential Functions Manage ... new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi… more
- Sunrise Systems Inc (New Brunswick, NJ)
- …preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience Skills/Knowledge Required: Experience with CMC ... CMC regulations Experience in post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… 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, ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Manager , Regulatory Affairs (Remote) Date:... CMC sections of submissions for assigned products. As Sr . Manager CMC Regulatory ... to make a difference with. **The opportunity** As the Senior Manager , Regulatory Affairs you...for assigned projects. **How you'll spend your day** As Sr . Manager , CMC Regulatory… more
- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- Taiho Oncology (Princeton, NJ)
- …team at Taiho Oncology where innovation thrives, and excellence is celebrated. As a Senior Manager in Analytical Development, you'll play a pivotal role in ... Sr . Manager , Analytical Development Princeton, NJ,...to ensure methods are developed and qualified to meet regulatory requirements, interacts with QA/ Regulatory / CMC … more
- Taiho Oncology (Princeton, NJ)
- …procurement operations and external supplier development and management. Position Summary: Senior Manager , Outsourcing and Vendor Management, supports and ... Sr . Manager , Outsourcing & Vendor Management...negotiation, and project award. + Ensures compliance with all regulatory and reporting requirements related to Supplier Diversity and… more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, ... product(s) with multiple driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director, or Director, in… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... with regulatory agencies, cross-functional teams, and stakeholders to develop and implement regulatory strategies. The Senior Manager of Regulatory … more
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located ... regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC... Regulatory Leads (GRLs) (Global Product Strategy or CMC ) and team members to enhance these relationships. +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs, is responsible for the development ... marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration...Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …delivery of safe life-changing therapies. **Job Summary:** Gilead Sciences seeks a Sr . Manager , Quality Assurance, in the Pharmaceutical Development and ... Manufacturing (PDM) organization. The Sr . Manager provides quality and compliance activities...ensures visibility and communication of key project timelines and CMC milestones + Acts in a project manager… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a Scientific ... of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for...in Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs. Key Responsibilities +… more
- J&J Family of Companies (Horsham, PA)
- Senior Manager , Product Quality Integrator - 2406182834W **Description** Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is ... recruiting for a ** Senior Manager , Product Quality Integrator-Launch & Grow...Represents Global Quality on the Chemistry, Manufacturing, and Controls ( CMC ) and Value Chain (VCT) Teams. Serves as liaison… more
- Actalent (Maryland Heights, MO)
- …the position will rely on the Canadian RA staff for country-specific regulations. The Senior Manager Regulatory Affairs will directly participate in project ... (Katie) is currently managing both the clinical and CMC portions, and they need someone to come in...but need experience working with cross functional teams. The Senior Manager of Regulatory Affairs… more
- BeiGene (San Mateo, CA)
- **General Description:** The Sr Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and ... improvements to build the organization for the future. The Sr Manager of Clinical Supply Chain leads...high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical… 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 ... As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg,… more
