- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is seeking a dedicated and innovative Director / Senior Associate Director , Global Regulatory Affairs CMC for Chemical products to join ... Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate...requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs. + Support complex, non-standard… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description The Associate Director 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...position is flexible. Applicants may be considered for the Senior Manager or Associate Director level based… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. + Multiple product development experiences… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** ... **RESPONSIBILITIES** The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Danaher Corporation (Fargo, ND)
- …Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be...the authoring, review and support of client filings including CMC submission in INDs, BLAs, NDAs, etc. + Primary… more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects.… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory policies ... dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing… more
- Novo Nordisk (Lexington, MA)
- …the therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Director of the Novel Modalities department Work with the ... you ready to make a difference? The Position The Senior International Medical Director serves as a...Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Senior Director , Clinical Development ... Senior Director Clinical Development - Respiratory...working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC , early clinical and pre-clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , PDM Product Strategy Leader** **Foster City, CA** **KEY ... in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory , or process development, or as part of a cross-functional… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... functional leadership (including but not limited to clinical Operation, Quality, Regulatory , CMC , and GRDS) to ensure alignment of organizations and prompt… more
- Novo Nordisk (Plainsboro, NJ)
- …within the therapeutic area, including PRO and biomarker strategies. Relationships Reports to: Senior Director of the Liver Disease department. Work with the ... you ready to make a difference? The Position The Senior International Medical Director serves as a...Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be… more
- Gilead Sciences, Inc. (Foster City, CA)
- … affairs organization. The incumbent will collaborate with patient safety, quality, regulatory CMC , commercial, clinical, and other development organizations on ... create possible, together. **Job Description** The Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and overseeing data… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of safe life-changing therapies. **Job Summary:** Gilead Sciences is currently seeking a Senior Director level position to be the leader of Packaging Quality ... leaders in in Portfolio Strategy team, Manufacturing, Packaging, Supply Chain, Regulatory CMC , and the wider PDM Quality organization to achieve business… more
- Bristol Myers Squibb (San Diego, CA)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Senior Director - Clinical Pharmacology will be a key member of the ... with the development strategy, program goals, and the US/international regulatory guidance for radiopharmaceuticals. + Collaborate with DMPK, clinical development,… more
- AbbVie (Irvine, CA)
- …Neurotoxin Research Group at AbbVie seeks an accomplished scientist and leader. The Director / Senior Principal Research Scientist will lead a team performing in ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Inflammation and Rare Disease** **What you will ... do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Inflammation and Rare Disease Therapeutic… more