- Gilead Sciences, Inc. (Foster City, CA)
- …create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for providing ... strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible for guiding… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC ... writing skills are essential for effectively communicating complex scientific information. As a Senior CMC Regulatory Sciences Specialist, a typical day… 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
- 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. ... through mapping resource across projects. In this role, the Senior CMC Project Manager is...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… 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 About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …duties as required. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability to work ... to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting...team. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability… 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 ... itwhere your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory … more
- Gilead Sciences, Inc. (La Verne, CA)
- …Sciences La Verne Engineering is seeking a highly motivated and knowledgeable ** Senior Manager , Project Management New Product Line Manufacturing - Labeling** ... Packaging, Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory / CMC , EHS, Finance, IT, and Engineering. **Project Team… more
- AbbVie (Worcester, MA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager of Program Management will lead the Manufacturing ... AbbVie's pipeline and our External Contract Manufacturing business partners. The Senior Manager provides project management leadership to ensure successful… more
- Sumitomo Pharma (Nashville, TN)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in ... of drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …tools to promote engaged, collaborative, and results-driven work environments. _The Senior Manager , Verification Programs has the following responsibilities:_ * ... guideline on the Common Technical Document (CTD) for pharmaceuticals, and/or regulatory Chemistry, Manufacturing Controls ( CMC ) submission experience. * Detail… more
- ThermoFisher Scientific (Greenville, NC)
- …client representative at site and build relationship with our investigators. **Role:** Senior CTM, Clinical Trial Manager , FSP Dedicated **Location:** US, ... co-monitoring the assigned international Ph 3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the… more
- BeOne Medicines (Pennington, NJ)
- Reporting to the Vice President, General Manager of US Manufacturing, Hopewell, NJ., this position plays a leading role in driving process robustness, technology ... and process troubleshooting. This position involves close collaboration with the CMC , Process Development, Manufacturing, Quality Control, Quality Assurance and … more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Senior Quality Control Analyst Department: Chemistry Location: Monroe, NC START YOUR APPLICATION ... Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager . Primary responsibilities for this position will be: perform QC analysis in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …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 ... Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop… more
- The Arora Group (Bethesda, MD)
- …Manager (RN-NCM) + National Academy of Certified Care Managers: Care Manager Certified ( CMC ) + Experience: + Referral Management/Utilization Management ... Registered Nurse Case Manager Nurse Currently recruiting a Registered Nurse (RN)...in obtaining services and support. + Serve as a senior nursing leader and advances the nursing profession in… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- WuXi AppTec (San Diego, CA)
- **Overview** Business Development Manager , Oligo Peptide Discovery (San Diego, CA) - Act as subject expert in biochemistry, uncover, develop, and grow contract ... in oligonucleotides and peptides new drug development by communicating with clients' senior scientists, chemists, and subject matter experts; Analyze and develop the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
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