- BeiGene (San Mateo, CA)
- …aggressive timelines. The individual will provide support to cross-functional teams on regulatory CMC strategies. **Essential Functions of the job:** + Develop ... and implement small molecule regulatory CMC strategies as well as author...submissions for investigational, marketing, and post-approval applications. + Develop regulatory strategy and execute the preparation of… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager . Participates in initiatives ... **Basic Qualifications** + Master's Degree with 3+ years of industry experience in CMC regulatory affairs; or Bachelor's Degree with 5+ years of pharmaceutical… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC Submission Management where you will support the execution of regulatory CMC investigational, registration and post-approval tasks for assigned products. ... CMC team, you will report to the Senior Manager GRA CMC and work with the...assigned projects (IND/ IMPD/ CTA/ MAA) according to the regulatory strategy laid out by GRA. +… 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
- United Therapeutics (Silver Spring, MD)
- …Manager partners with senior regulatory leadership on the development of regulatory strategy , providing regulatory advice and oversight to project ... the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical...a Bachelor's degree + 3+ years of experience with regulatory strategy and submissions for biologics and/or… more
- Actalent (Boston, MA)
- …deliverables including MW, regulatory and PV * Serve as point of contact/alliance manager for selected regulatory vendor(s) * Plan and execute regulatory ... & Responsibilities: * Manage submission-related activities o Working with Reg Dev and CMC leads, create content plans and submission timeline for regulatory … 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
- Gilead Sciences, Inc. (Foster City, CA)
- …execution of multiple small molecules and/or biologics CMC programs. The Sr. Project Manager will partner with PDM Product Strategy Team Leads to manage a ... , Project Management** **Location: Foster City** **Specific Responsibilities:** The Senior Project Manager in PDM Portfolio Strategy and Operations will be… more
- Integra LifeSciences (Plainsboro, NJ)
- …** provides the oversight and management of the Collagen Manufacturing Center ( CMC ) occupational health, safety and environmental strategy , policies, related ... EH&S services to the office and manufacturing personnel within the Integra CMC facility. + Establishes and monitors standards, policies, and procedures for… more
- Merck (Rahway, NJ)
- …manufacturing, testing and release processes for products supported. + Understanding of regulatory strategy with respect to new product introduction (GFLS) and ... (GHH) brand/ franchise commercial goals. The Biologics VCM Product Manager (PM) works under direction of the VCM Product...+ Understanding of product development lifecycle and integration of CMC and clinical strategy to bring a… more
- Merck (Boston, MA)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Regeneron is seeking a highly motivated ** Manager , Scientific Writing** to supervise regulatory submission drafting activities for preclinical pharmacokinetics ... content (PK, Toxicology, and Pharmacology) as well as select documents supporting CMC and Clinical Pharmacometrics content. **A Typical Day Looks Like:** + Coach… 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
- Eurofins (Salt Lake City, UT)
- …GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC laboratory services for the world's largest pharmaceutical and biopharmaceutical ... control. Position Summary Eurofins BPT is seeking a results-oriented Regional Sales Manager to join our team, focusing on facility validation and environmental… more
- Fujifilm (Holly Springs, NC)
- …alignment with our contracted commitment to clients and our company vision / mission ( strategy and compliance). The Sr. Program Manager handles an average load ... States. **External US** **About This Role** The Senior Program Manager is accountable for the planning and delivery of...operations (DS / DP / FG) as well as CMC and regulatory aspects + Experience with… 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 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
- Fujifilm (Holly Springs, NC)
- …knowledge of biopharmaceutical manufacturing operations (DS / DP / FG) as well as CMC and regulatory aspects + Ability to lead, coach, develop, and motivate ... in alignment with our contracted commitment to clients and our company vision/mission ( strategy and compliance). The APD handles an average load of 1-3 larger and… 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
- Vera Therapeutics (Brisbane, CA)
- …standards. * Collaborate and establish/maintain procedures in collaboration with CMC Operations, Clinical Development, Clinical Operations, Regulatory Affairs, ... from immunological diseases. Position Summary: Reporting into the Senior Vice President, Regulatory and Quality, the Vice President, Quality will be responsible for… more