- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with… more
- Aequor (Seattle, WA)
- …Business HoursHybrid: (50%&plus days onsite required, days of week are flexible)Job ID: 62721Per manager , the Top 3 - 5 Must Have's a candidate should have are:Top ... large data sets in support of batch history sections for regulatory submissions.Proficiency in data management/statistical analysis software, including Excel, JMP,… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid ... Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory...of 1 year of experience in pharmaceutical development, manufacturing, CMC regulatory , project management, and/or… more
- Regeneron Pharmaceuticals (Troy, NY)
- …of responses to regulatory agency inquiries. + Act as the project manager related to program submission strategies, including timelines, approach, and ... We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to...may be for you if you have: + Strong project management and communication skills. + Ability to work… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy...Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge… more
- Charles River Laboratories (Rockville, MD)
- …help you build a career that you can feel passionate about. **Job Summary** The Senior CMC Project Manager leads project execution after deal closure. ... mapping resource across projects. In this role, the Senior CMC Project Manager is the...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- Lilly (Lebanon, IN)
- …a successful startup into GMP manufacturing operations. **Position Description:** The CMC Project Management Professional is responsible for overseeing the ... Chemistry, Manufacturing, and Controls ( CMC ) activities for our pharmaceutical products. This role requires...from portfolio entry to global submissions/approvals and launch. The Project Manager is expected to have commercial… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager , Regulatory Affairs Date: Jun 3, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 61795 **Who we ... spend your day** Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester,...Authority Applications (directly or indirectly) + Authoring and Reviewing CMC content for use in Health Authority Applications +… more
- Fresenius Medical Center (Knoxville, TN)
- …to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support ... The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as … more
- Vera Therapeutics (Brisbane, CA)
- …development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory ... Title: Senior Manager , Clinical Regulatory Location: Brisbane, California...content that meets current regional requirements * Represent clinical Regulatory Affairs on cross-functional project teams *… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- AbbVie (Worcester, MA)
- …The Senior Manager of Program Management will lead the Manufacturing Project Management Office (MPMO) supporting six manufacturing suites at ABC and driving the ... and our External Contract Manufacturing business partners. The Senior Manager provides project management leadership to ensure...Processes, QA, QC and Engineering + Sound understanding of regulatory requirements to guide team and project … more
- Gilead Sciences, Inc. (La Verne, CA)
- …Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory / CMC , EHS, Finance, IT, and Engineering. ** Project Team Management:** + ... transfer team can deliver products to meet compliance with regulatory requirements, Current Good Manufacturing Practices (cGMPs), Good Laboratory...or MBA. + 3+ years successfully serving as a project manager . + Proven experience in managing… more
- BeOne Medicines (Emeryville, CA)
- …cost-effective production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new ... **_General Description:_** Sr. Manager /Associate Director, Supply Chain CMO Management & PM...a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements **Computer… more
- Bausch Health (Bridgewater, NJ)
- …aspects of product development team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is ... and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned… more
- ThermoFisher Scientific (Wilmington, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- AbbVie (North Chicago, IL)
- …Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC - Regulatory . Responsibilities: + Manager a small team (3 ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
- Amgen (Thousand Oaks, CA)
- …transform the lives of patients while transforming your career. **Regional Operations Lead Manager ** **What you will do** Let's do this! Let's change the world! As ... Amgen expands globally, the Regional Operations Manager is a key position in implementing the Latin-America-Canada (LACAN) Region's commercial strategy, product… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to ... the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's… more
- ThermoFisher Scientific (Greenville, NC)
- …co-monitoring the assigned international Ph 3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the ... deliverables within a matrix organization under the leadership of the Clinical Project Managers (CPM). Be a client representative at site and build relationship… more
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