- J&J Family of Companies (Raritan, NJ)
- …& Johnson Innovative Medicine R&D is recruiting for a Regulatory Affairs (RA) Professional , CMC (Chemistry, Manufacturing and Controls) Certificates ... Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job Category:** Professional ...globally is preferred. + Knowledge of Regulatory Affairs Chemistry, Manufacturing and Controls ( CMC ) is… more
- Gilead Sciences, Inc. (Foster City, CA)
- …scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and CMC technical areas of ... and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible… more
- Chiesi (Boston, MA)
- …Who we are looking for Purpose Currently seeking for a Regulatory Affairs Specialist to support preparation of CMC related submissions and assessment of ... benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of... Affairs specifically with Small Molecules focused on Regulatory CMC + Good understanding of the… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in ... various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that data are identified,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... guide the team to define and drive strategy for CMC regulatory dossier content and reviews this... success, exercising sound judgement and communicating in a professional and timely manner. Acts as an advisor and… 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 ... technology, drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development… more
- BeOne Medicines (San Mateo, CA)
- …an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … more
- Gilead Sciences, Inc. (Washington, DC)
- …**QUALIFICATIONS** + A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of ... Join Gilead and help create possible, together. **Job Description** The Director, CMC Regulatory Affairs Policy, Advisory and Intelligence is part of a… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Ascendis Pharma (Palo Alto, CA)
- …RA project lead of BLA and/or NDA filings + Minimum 12 years of documented professional experience at a Regulatory Affairs leadership position within the ... in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic...on North and South America + Experience with biologics, CMC , Toxicology, Orphan Drugs development, breakthrough and fast track… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** **Live** ... you will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology Therapeutic Area. Global … more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What you will ... do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global Regulatory … 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, ... business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, … 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 ... regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) +...much experience you bring with you - for your professional future with meaning: + The opportunity to work… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… more
- Sanofi Group (Morristown, NJ)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... Research and Development. Sanofi's global regulatory affairs (GRA) function is comprised of...+ Proven ability to work cross-functionally in a highly professional global environment. **Skills/Qualifications:** + MS degree -in a… more
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... Research and Development. The selected candidate will oversee key regulatory activities and report to the Global Regulatory Device Head for Digital Health and… more
- AbbVie (North Chicago, IL)
- …Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs , R&D, and S&T to align strategic initiatives. ... Develop regulatory strategies for brands with Regulatory Affairs . Responsibilities List up to 10 main responsibilities for the job. Include information about… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) and/or from the Regulatory Affairs Professional Society (RAPS) as a Regulatory ... guideline on the Common Technical Document (CTD) for pharmaceuticals, and/or regulatory Chemistry, Manufacturing Controls ( CMC ) submission experience. * Detail… more