- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs. This position can be located in Spring House, PA; Horsham, PA; Titusville, ... and commercialization. This person is responsible for developing global CMC regulatory strategies. The primary responsibility is... senior member of the department. + Reviews CMC regulatory dossiers for global submissions throughout… more
- 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
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... regulatory strategies and provides mentoring and coaching to Sr . Scientist and Assoc Principal scientist in support of...but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide … more
- Vera Therapeutics (Brisbane, CA)
- …team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible for working with the cross-functional team ... Job Title: Senior Manager, Regulatory CMC Location: Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on… more
- Takeda Pharmaceuticals (Lexington, MA)
- …development plans. As part of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally across the business. **How you ... where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products… 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
- J&J Family of Companies (Malvern, PA)
- Johnson & Johnson is recruiting for a Senior Director , Antibody Conjugates, CMC Portfolio Management located in Malvern, PA. This leadership position will ... timelines for the antibody conjugate portfolio. In addition, the role will oversee CMC regulatory submissions and responses to deliver clinical and launch drug… 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)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... experience and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management of review and approval of NDA/MAA/BLA… 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
- Charles River Laboratories (Rockville, MD)
- …you build a career that you can feel passionate about. **Role Summary** The Sr . Director Operations leads the development, implementation, and adherence to all ... GMP procedures and policies related to commercial production. The Sr . Director has oversight of Materials Management, MS&T and Manufacturing and is responsible… 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
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals ( Senior /Executive Director ) OBJECTIVES/PURPOSE + ... a network of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global… more
- Integra LifeSciences (Plainsboro, NJ)
- … agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** Manages personnel ... system requirements and how they impact product quality and regulatory compliance. + Works with Senior Management...quality and regulatory compliance. + Works with Senior Management to achieve alignment of Quality Goals and… more
- Danaher Corporation (Chicago, IL)
- …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
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