- Unknown (Cambridge, MA)
- …The VP will be tasked with establishing and overseeing technical standards, driving CMC planning for global regulatory submissions, and leading a high-performing ... Vice President, CMC Technical Development About the Company Clinical-stage biotechnology...science, analytical development, and a strong working knowledge of regulatory requirements are essential. The role also demands a… more
- Unknown (Dallas, TX)
- …least 15 years' experience in large pharma and CMOs. Technical proficiency in CMC development and manufacturing, regulatory expertise, and a proven track record ... Executive Director or Vice President, Commercial CMC About the Company Industry leading open-access biologics technology platform Industry Pharmaceuticals Type… more
- Unknown (Foster City, CA)
- …in drug development and manufacturing, and a comprehensive understanding of CMC requirements, regulatory frameworks, and global manufacturing trends, are ... essential. The ideal candidate will be a strategic thinker, capable of influencing and challenging the status quo, and will have a history of effectively managing complex projects and leading cross-functional initiatives. Hiring Manager Title SVP of… more
- Unknown (Gaithersburg, MD)
- …disease oncology immtacs immune system hiring biologics autoimmune jobs scientists regulatory affairs and cmc biotechnology cancer infectious diseases autoimmune ... Vice President, Regulatory Affairs About the Company Thriving T-cell receptor...Role The Company is seeking a Vice President of Regulatory Affairs to lead a team in the development… more
- Unknown (Boston, MA)
- …field of oncology. The Vice President will be responsible for all aspects of regulatory affairs, including global strategy, CMC , operations, and management of ... Vice President of Regulatory Sciences About the Company Innovative biotechnology (BioTech)...Role The Company is seeking a Vice President of Regulatory Sciences to join their dynamic team. The successful… more
- Unknown (Union City, CA)
- …overseeing stability studies, and acting as the analytical subject matter expert in CMC development and regulatory discussions. Applicants for the Head of ... characterization techniques and a strong understanding of quality and regulatory standards are essential. Familiarity with DoE approaches, statistical tools,… more
- Unknown (Boston, MA)
- …initiatives. A key aspect of the role is to ensure the delivery of CMC operations that meet regulatory , quality, and technical standards. The VP will ... and maintain strategic partnerships, lead contract negotiations, and oversee CMC operations with a focus on regulatory ...oversee CMC operations with a focus on regulatory and quality compliance. A deep understanding of the… more
- Unknown (Oklahoma City, OK)
- …disease oncology immtacs immune system hiring biologics autoimmune jobs scientists regulatory affairs and cmc biotechnology cancer infectious diseases autoimmune ... of publications and medical information teams. A strong commitment to ethical, regulatory , and scientific standards is essential, as is the ability to drive… more
- Unknown (Washington, DC)
- …disease oncology immtacs immune system hiring biologics autoimmune jobs scientists regulatory affairs and cmc biotechnology cancer infectious diseases autoimmune ... diseases t cell receptor immunotherapy immtax immtac immtav and immtaai About the Role The Company is seeking a Vice President for Corporate Business Development to play a pivotal role in the strategic growth of the organization. The successful candidate will… more
- Unknown (Conshohocken, PA)
- …disease oncology immtacs immune system hiring biologics autoimmune jobs scientists regulatory affairs and cmc biotechnology cancer infectious diseases autoimmune ... diseases t cell receptor immunotherapy immtax immtac immtav and immtaai About the Role The Company is seeking an Executive Director for Medical Affairs in the United States. This pivotal role is focused on the development and implementation of US-specific… more
- Unknown (Fort Worth, TX)
- …of radiolabeling and radioisotope production, ensuring strict adherence to GMP and CMC regulations. The Vice President will also be responsible for setting the ... and presentation skills, a deep understanding of GMP and CMC regulations, and a passion for innovation in the...to staying abreast of the latest scientific advancements and regulatory changes, and will have the opportunity to represent… more
- Unknown (Gaithersburg, MD)
- …Collaboration with cross-functional teams, including R&D, Quality, Manufacturing, and Regulatory Affairs, is essential for the successful development of process ... optimization. Skills in GxP compliance, data integrity, and a diversified experience in CMC development for cell therapeutics are also required. The role demands a… more
- Unknown (Lexington, MA)
- …to engage with senior leadership, health authorities, and KOLs. A background in CMC , particularly in gene therapy or biologics, and experience in developing ... regulatory documents and strategy are also required. The role demands a proactive, can-do attitude, and the ability to thrive in a collaborative, mission-driven… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Director, CMC Regulatory will leverage CMC technical knowledge and regulatory ... science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the delivery of all relevant… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... Leads the Chemistry, Manufacturing, and Controls ( CMC ) & Combination Products (CP) Internal Medicine team....be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role… more
- BeOne Medicines (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …related subject. The summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed applications in line ... the following:** A summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs...in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus… more
- AbbVie (North Chicago, IL)
- … CMC development of peptides and sterile injectables. This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and ... FDA) regarding CMC matters. Scope of Responsibility: + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including… more
- Takeda Pharmaceuticals (Boston, MA)
- …as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned ... strategy. + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
