- 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 ,...( CMC RS) staff/direct reports (including contributing to regulatory strategy discussions, project direction, and ensuring… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of ... timely manner + Stay abreast of current and evolving regulatory CMC requirements, apply this knowledge to...to support their development + May serve as direct/matrix manager of RAV CMC staff, depending on… more
- Lilly (Indianapolis, IN)
- …program teams. Work with CMC and program team members to operationalize CMC strategy and integrate into the cross-functional program schedule. + Manage ... make life better for people around the world. **Associate Director** **; CMC , Device Development Program Manager ** **Functional Area: Technical Operations** At… more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy , US & Canada, AbbVie Inc., ... driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director,...or Director, in the development & execution of the regulatory strategy . . Serve as HA liaison… more
- CSL Behring (King Of Prussia, PA)
- …and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC ) and team members to enhance these relationships. + ... often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position...contribute regional regulatory perspective to the global regulatory strategy and aligning regional strategies with… 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 ... Regulatory Affairs (GRA) Process Excellence function, responsible for driving... Affairs, as well as cross-functional stakeholders (eg, RA CMC , R&D Excellence, Clinical Operations, IT). **Responsibilities** **Operate within… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …responsible for the development and execution of the post-approval regulatory strategy , post-marketing commitments,post-marketing development and maintenance, ... Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and...for approved products. + Develops FDA/OPDP and Health Canada strategy and execution of related communications as part of… 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 Biotherapeutics** ! The...and Grow Biotherapeutics has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization… more
- LA Care Health Plan (Los Angeles, CA)
- …impacts to current processes and supports implementation initiatives. Assess market strategy white papers, Legal memos, legislation/mandate language, regulatory ... Product Solutions Manager III Job Category: Administrative, HR, Business Professionals...for assisting the product leadership team within the Product Strategy , Sales and Marketing (PSSM) service area and the… more
- Merck (Boston, MA)
- …partner organizations such as Clinical Sciences and Study Management (CSSM), Regulatory , Chemistry, Manufacturing and Controls ( CMC ), Pharmaceutical Sciences, ... patient continuity of supply. Working independently, the Clinical Supplies Project Manager (CSPM) designs strategic and operational plans for all activities… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Regulatory , Analytical, Supply Chain, and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer, commercialization, ... or Commercial CMC teams with responsibility for proactively managing product strategy across the life cycle from clinical supply to commercial product launch and… more
- Randstad US (Cambridge, MA)
- …industry and Project management experience within Medical Affairs, Clinical Research, Regulatory , CMC , Marketing or other drug development related function ... usa - program manager - business professional. + cambridge , massachusetts...GMSO Program Management team, you will report to the Strategy & Operations Lead, Gastroenterology + Leads the program… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Regulatory , Analytical, Supply Chain, and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer, commercialization, ... or Commercial CMC teams with responsibility for proactively managing product strategy across the life cycle from clinical supply to commercial product launch and… 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 ... future senior talent and leaders. + Provides technical scientific expertise to CMC analytical project strategy groups and decision-making processes. Makes… more
- BeiGene (San Mateo, CA)
- …and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand ... **General Description:** The Sr Manager of Clinical Supply Chain manages drug supply...Coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations, CRO) and CMOs. + Support IRT… more
- Taiho Oncology (Princeton, NJ)
- Sr. Manager , Outsourcing & Vendor Management Princeton, NJ, USA Req #339 Tuesday, March 12, 2024 Looking for a chance to make a meaningful difference in the oncology ... and expanding mid-size company in the role of Sr. Manager , Outsourcing and Vendor Management. Your expertise will play...play a pivotal and visible role in advancing outsourcing strategy and management for R&D categories at Taiho. You'll… more
- Amgen (Cambridge, MA)
- …sites. + Author technical reports and analytical Chemistry, Manufacturing and Controls ( CMC ) sections in regulatory documents. Address analytical and product ... peptide drug substances and products. + 2+ years' experience as a people manager + Strong understanding of small molecule analysis and structure elucidation informed… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for the identification and design of a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ... generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC , IP, patient selection,… more
- Editas Medicine (Cambridge, MA)
- …significant clinical components and implications. + Collaborate closely with Non-clinical, Regulatory , Clinical Operations, CMC and Biometrics to ensure tight ... Development will play a key role in leading the strategy , development, and execution of the clinical pipeline. The...The incumbent is expected to have a strong clinical, regulatory and scientific foundation, and will work closely with… more
- Bausch Health (Bridgewater, NJ)
- …(Quality plan/quality strategy ) + Perform other duties assigned by the Manager R&D Quality and Quality Leadership as required Qualifications: + Bachelor's Degree ... and ensures adherence to CGMP compliance in a regulated environment. Support the Manager of R&D Quality who is responsible for the effective management of the… more