- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions:...and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation,… more
- Merck & Co. (Rahway, NJ)
- …Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Pfizer (Kalamazoo, MI)
- …of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the ... help Pfizer develop and implement chemistry, manufacturing and control ( CMC ) regulatory strategies for small and large...of pending registrations and respond to queries. As a Manager , you provide guidance to operational teams for managing… more
- Astellas Pharma (Westborough, MA)
- …remote work are encouraged to apply. **Purpose and Scope:** Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects ... ** Regulatory Manager , Regulatory Affairs - CMC...against regulatory requirements and reviews submissions against regulatory strategy . Ensures proper CMC … more
- Gilead Sciences, Inc. (Foster City, CA)
- … impact and plans global amendments + Coordinate and facilitate development of Regulatory CMC strategy with development teams, affiliates for local ... worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal ... and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass...that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy ...experience and 4+ years direct or related CMC regulatory experience + Successful track record… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57668 **Who we are** ... SOPs (Standard Operating Procedure) and requirements as applicable. Assist in providing regulatory strategy for assigned R&D projects to R&D, and applicable… more
- Takeda Pharmaceuticals (Boston, MA)
- …transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about ... development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and… 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
- 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
- Schrodinger (Cambridge, MA)
- …stakeholders including DMPK, translational medicine, clinical development, clinical operations, regulatory , CMC , and project management to ensure completion ... We are looking to hire a **Senior Manager /Associate Director of Clinical Pharmacology** to join us...can utilize soft skills to guide, lead, and influence strategy /direction of programs + A drug development veteran who… more
- Taiho Oncology (Princeton, NJ)
- Sr. Manager , Outsourcing & Vendor Management Princeton, NJ, USA Req #339 Friday, June 28, 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
- Amazon (North Reading, MA)
- …well-established yet rapidly expanding team. This position reports directly to the Sr Manager of Regulatory Compliance. Key job responsibilities * Applying IEC ... Description We are seeking a Senior Manager for our functional safety engineering development team....will be your job to help drive engineering and strategy for our new and often novel approaches to… 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 Associate Manager of Clinical Supply Chain manages drug supply...coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations, CRO) and CMOs. + With minimal… more
- Novo Nordisk (Lexington, MA)
- …Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 in Clinical Development program(s), Dosage and administration ... strategy , including dose setting and dosing regimen for project(s),...Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory , Data Science (statistics, pharmacometrics), Research and Early Development,… more
- Takeda Pharmaceuticals (Boston, MA)
- …and accountable for overarching Global Program(s). The GPL defines the asset strategy and leads all development and Life Cycle Management projects associated with ... speed/cost to market (eg innovative trial designs, improving governance processes, asset strategy etc.) GPLs must + be experienced, versatile and strong enterprise… more
- Covenant Health Inc. (Crossville, TN)
- Overview RN Care Manager I, Continuum of Care Full Time, 80 hours per pay period, Day shift Covenant Health is the region's top performing healthcare network. Each ... seriously ill patients, advanced medical and surgical care is provided at CMC including telemetry monitored beds and an intensive care unit. Additionally, Cumberland… more
- Merck (Rahway, NJ)
- …Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Amicus Therapeutics (Princeton, NJ)
- …by partnering with key stakeholders including but not restricted to CMC , Clinical, Clinical Operations, Regulatory , Patient Advocacy, IP/Legal, Finance. ... cross-functional coordination for execution of development workstreams, in line with brand strategy set by Brand Leadership Teams, creates and monitors timelines and… more
