- 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
- 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …employment role in the capacity of Senior Associate in Gilead's Regulatory Affairs CMC department. **Job Description:** + Responsible for the preparation ... than 35 countries worldwide, with headquarters in Foster City, California. **Sr. Associate, CMC Regulatory Affairs - Biologics** Gilead Sciences is seeking a… 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 ... assistance from other health care professionals within the system and from regulatory agencies. 8. Protects patients and employees by developing and interpreting… 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
- 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
- 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
- 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply ... but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls ( CMC ), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing… more
- Integra LifeSciences (Plainsboro, NJ)
- …of us are challenging what's possible and making headway to help improve outcomes. The ** Senior Project Manager ** is a key member of the value stream leadership ... team for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager , this position is… more
- Integra LifeSciences (Plainsboro, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Senior Manager , Manufacturing is responsible for plant production activities for ... CMC (Collagen Manufacturing Center). This includes assigning and monitoring...minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all assigned… 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 ... environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist, Regulatory Project Management (RPM) role is responsible… more
- Bausch Health (Petaluma, CA)
- …with accuracy and in accordance with established procedures + Effectively communicates with Manager , team members, and Senior Management + Organized and able to ... impact. DESCRIPTION OF JOB: Creates and executes extensive analytical and CMC development plans for pharmaceutical active ingredients, excipients, oral and topical… more