- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC ... and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through all phases… more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Senior Manager , Regulatory CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company ... for patients suffering from immunological diseases. Position Summary: Vera is seeking a Senior Manager , Regulatory CMC to join an experienced, fast-paced… 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
- 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Sr . Associate, CMC Regulatory Affairs - Biologics** Gilead Sciences ... the capacity of Senior Associate in Gilead's Regulatory Affairs CMC department. **Job Description:** +...the product license. + Develop and maintain knowledge of regulatory requirements independently and with line manager .… 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
- Novo Nordisk (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
- 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
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- QC Stability, Senior Manager - Monroe, NC Department: Chemistry Location: Monroe, NC START YOUR APPLICATION ... oversight, and ensure compliance with internal procedures, industry regulations and regulatory guidance documents. Write, execute, and manage the stability program… more
- Actalent (Bridgewater, NJ)
- Job Title: Senior Program Manager Job Description The incumbent will lead a team of program management professionals, spearhead key organizational growth ... for cross-functional development projects, including the project management of CMC , clinical, and regulatory activities. Responsibilities include strategy… more