- 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 focused on ... from immunological diseases. Position Summary: Vera is seeking a Senior Manager , Regulatory CMC to join an experienced, fast-paced and collaborative… more
- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Manager , CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage ... **Salary:** $130,000-160,000/year **Workplace:** Onsite in Seattle, WA **Overview** The Manager , Regulatory Affairs ( CMC ) is responsible for providing … 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
- 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 CTD CMC sections for assigned projects to ensure on-time and high-quality global… 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 approvals. Develops and manages content strategy… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ Participate in cross-functional meetings for program-specific discussions, proactively identify CMC regulatory issues and suggest appropriate strategies to ... Support CMC development activities from a regulatory standpoint during early phase, development, submissions and post market requirements for gene therapies. **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 ... Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this...according to agreed business priorities. + As a line manager role, provides project and administrative oversight to support… 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 ... Qualifications** + Master's Degree with 3+ years of industry experience in CMC regulatory affairs; or Bachelor's Degree with 5+ years of pharmaceutical CMC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr. Associate, CMC Regulatory Affairs - Biologics** Gilead Sciences is seeking a ... the product license. + Develop and maintain knowledge of regulatory requirements independently and with line manager ....with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC … 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
- 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
- UTMB Health (Huntsville, TX)
- Business Manager Inpatient Ops - CMC - Huntsville **Huntsville, Texas, United States** **New** Business, Managerial & Finance UTMB Health Requisition # 2405477 ... mechanisms to monitor and enforce compliance with local, state, and national regulatory agencies. Interprets new and changing rules and regulations and ensures… more
- Actalent (Boston, MA)
- …to avoid deficit spending. As necessary, work with investigators and RAD to manager deficits. + Responsible for managing all time and effort reporting for defined ... Grants management, budget preparation and financial management principles and regulatory requirements. + Previously demonstrated understanding of policy and practice… more
- Atlantic Health System (Pompton Plains, NJ)
- …assistance from other health care professionals within the system and from regulatory agencies. 8. Protects patients and employees by developing and interpreting ... infection-control policies and protocols; enforcing medication administration, storage procedures, and controlled substance regulations. 9. Maintains and works among the health care teams by communicating information; responding to requests; building rapport;… more
- Actalent (Cambridge, MA)
- …Regulatory Submissions Specialist to manage submission-related activities, working closely with regulatory and CMC leads to create content plans and ... with IND and BLA submissions. Responsibilities + Work with regulatory and CMC leads to create content...+ Serve as the point of contact and alliance manager for selected regulatory vendors, ensuring timely… more
- United Therapeutics (Silver Spring, MD)
- …Contribute to the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial ... diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory leadership on the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …At Takeda, we empower you to shape your future. Join us as a Manager of Statistics at our Cambridge, MA office, where every individual's contribution is valued. ... role, you'll play a key part in our bold and inspiring mission. As Manager of Statistics, you will provide statistical leadership in the design, analysis, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... technical objectives (project and scientific related) with input from manager as needed. + Identify and recommend vendors as...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory… more
- System One (Florham Park, NJ)
- …meetings to provide input on submission timelines in collaboration with Manager , Regulatory Operations. + Ensure consistency across regulatory ... appropriate by manager . + Maintain knowledge of local and global regulatory submission requirements. + Assist in supporting Regulatory Operations' technology… more