- 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 ... Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU...and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to assist with overflow in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director. Works with personnel ... to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to...tasks and assignments Participates in department forum meetings eg CMC , PRB, and ensures that proper minutes from these… more
- Novo Nordisk Inc. (Boulder, CO)
- …and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product ... new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi… more
- Novo Nordisk Inc. (Boulder, CO)
- …API. Relationships The Technician II, API Manufacturing reports to the Senior Manager , API Manufacturing. Essential Functions Provides support for ... new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi… more
- Merck & Co. (Rahway, NJ)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... Job Description Job Description: - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research &… more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Senior Manager , Regulatory CMC Location: Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... for patients suffering from immunological diseases. Position Summary: Vera is seeking a Senior Manager , Regulatory CMC to join an experienced, fast-paced… more
- AbbVie (North Chicago, IL)
- …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 approvals. Develops and manages content strategy for… more
- 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...needed throughout product life cycle. Escalate critical issues to senior management. + Lead or contribute to development of… 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 ... their aspirations. Join Gilead and help create possible, together. **Job Description** ** Sr Associate, Regulatory Affairs, CMC ** **Foster City, California**… more
- Takeda Pharmaceuticals (Lexington, MA)
- … where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products ... implements effective development plans. As part of the GRA CMC team, you will report to the Senior...Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this… 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 ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… more
- Kelly Services (Vancouver, WA)
- Kelly(R) Science & Clinical is seeking a CMC Project Manager opportunity with a generative AI biotechnology company in Vancouver, WA. If you're passionate about ... and regulatory requirements. + Proven track record in supporting CMC programs from development to commercialization. + Experience in biotech, pharmaceutical, or… more
- Atlantic Health System (Pompton Plains, NJ)
- …data to measure the effectiveness of patient care. 4. Works with senior leadership, interdisciplinary teams and other stakeholders in order to develop, implement ... other health care professionals within the system and from regulatory agencies. 8. Protects patients and employees by developing...of AllSpire Health Partners. We have received awards and recognition for the services we have provided to our… more
- West Pharmaceutical Services (Exton, PA)
- …ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical device life-cycle Management, including ... Sr . Specialist, Regulatory Project Management (Evergreen...and planet through our sustainability efforts. **Job Summary:** This Senior Specialist, Regulatory Project Management (RPM) role… more
- Gilead Sciences, Inc. (Foster City, CA)
- …will be responsible for the planning and execution of multiple small molecules and/or biologics CMC programs. The Sr . Project Manager will partner with PDM ... Join Gilead and help create possible, together. **Job Description** **Title: Sr . Manager , Project Management** **Location: Foster City** **Specific… more
- Fujifilm (Holly Springs, NC)
- …in Holly Springs, North Carolina, United States. **External US** **About This Role** The Senior Program Manager is accountable for the planning and delivery of ... our company vision / mission (strategy and compliance). The Sr . Program Manager handles an average load...operations (DS / DP / FG) as well as CMC and regulatory aspects + Experience with… more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. This ** Senior Manager , Quality Operations** will manage and provide oversight on ... understand quality system requirements and how they impact product quality and regulatory compliance. + Works with Senior Management to achieve alignment… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… more
- United Therapeutics (Silver Spring, MD)
- …cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior ... Contribute to the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial… more
- System One (Florham Park, NJ)
- Senior Regulatory Operations Associate Contractor (Publishing) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) ... Senior Regulatory Operations Associate Contractor The ...to provide input on submission timelines in collaboration with Manager , Regulatory Operations. + Ensure consistency across… more
