- 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
- 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
- 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
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Dossier Leadership will lead an ... team responsible for the creation and management of high-quality CMC submission strategies and Module 3 regulatory ...short-term and long-term plans to achieve goals set by senior management. Drive consensus for goals to meet the… 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 ... within overall CMC development project(s), to support Sr CMC Lead. In case no ...- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or… more
- AbbVie (Irvine, CA)
- …innovative pipeline of neurotoxins with significant technical complexity. Reporting to the Senior Director of Drug Product Development, the individual will lead ... optimize lab processes. + Ensure compliance with AbbVie safety, quality, and regulatory policies, as well as relevant government regulations. + Implement and manage… more
- Takeda Pharmaceuticals (Boston, MA)
- …industry experience including significant experience in analytical science, cGMP compliance, CMC regulatory requirements in multiple analytical development areas ... regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Develop, implement and execute a smart… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** **RESPONSIBILITIES** The Sr Director , Analytical ... to operate" throughout the product lifecycle. In addition, the Sr Director will be accountable for leading...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Biologics Drug Product MSAT** Gilead Sciences, Inc. is ... stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development, Supply Chain and other… more
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual for a newly created Director / Senior Director role in Process Chemistry in either Frontier's South ... scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to support all development… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... of drug candidates to support clinical trials, product commercialization, and regulatory submissions. The position presents an opportunity to lead dynamic teams… 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
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… 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
- Lilly (Indianapolis, IN)
- …the users' needs and intended uses. **Position Summary:** DDCS is seeking a Senior Director , Packaging Systems to lead, support, and manage container closure ... and delivery device pipeline portfolio. This individual must be versed in CMC development, materials evaluation, and packaging systems design and development to… 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
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