- AbbVie (North Chicago, IL)
- …. Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for ... + MD **Preferred Qualifications** + Has 5+ years of relevant experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.… more
- Amgen (New Albany, OH)
- The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for ... manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop solutions to… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more
- Vera Therapeutics (Brisbane, CA)
- …including Research, Clinical Pharm, Analytical Science, Drug product, Quality Assurance, Regulatory Affairs , Supply chain, Finance, and Program Management. Write ... Title: Senior Manager , Early-Stage Biologics Development, CMC Location:...teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: *… more
- Sumitomo Pharma (Columbus, OH)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Regulatory Affairs ** . The Senior Manager is ... part of the Global Regulatory Affairs (GRA) team based in the US and he/she...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Amgen (Washington, DC)
- …worldwide. Become the professional you are meant to be in this meaningful role. ** Regulatory Affairs Manager - Combination Products** **What you will do** ... years of pharma/biotech and/or medical device and combination products regulatory affairs experience + OR + Bachelor's...+ Experience in drug delivery device or diagnostics device regulatory submission process + Regulatory CMC… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and… more
- Bausch Health (Bridgewater, NJ)
- …and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Fresenius Medical Center (Knoxville, TN)
- …+ Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a ... to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support… 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. (Columbus, OH)
- …Successful engagement in multiple initiatives simultaneously + Certification (such as Regulatory Affairs Professionals Society (RAPS)) + Prior project management ... The Sr. Manager , CTA Regulatory Strategy is responsible...budgets + Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC… more
- Vera Therapeutics (Brisbane, CA)
- …with key stakeholders including Drug Product, Analytical sciences, Quality Assurance, Regulatory Affairs , Supply chain, Finance, and Program Management. Write ... Title: Senior Manager , Process Development, Downstream Location: Brisbane, CA About...review, or edit cGMP batch records, change controls, deviations, CMC regulatory and quality documents. * Participate… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …Society for Quality (ASQ) as a Certified Quality Auditor (CQA) and/or from the Regulatory Affairs Professional Society (RAPS) as a Regulatory Affairs ... guideline on the Common Technical Document (CTD) for pharmaceuticals, and/or regulatory Chemistry, Manufacturing Controls ( CMC ) submission experience. * Detail… more
- BD (Becton, Dickinson and Company) (El Paso, TX)
- …**:** The Staff Quality Engineer works closely with shared functions (eg Regulatory Affairs , Designated Complaint Handling Unit (DCHU), Sterility Assurance, ... Supply Chain, and Finance. The Sr. / Staff Quality Engineer interacts with Regulatory Affairs regarding new regulations and standards as they apply to… more
- UTMB Health (Galveston, TX)
- …and related to appropriate compliance with Medicare and Medicaid statutory and regulatory requirements. + Supports UTMB Legislative Affairs department with ... experience, with at least six years of reimbursement experience at manager level or above. **Preferred Qualifications:** + Master's degree in accounting… more
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