- Revolution Medicines (Redwood City, CA)
- A precision oncology company is seeking a CMC Regulatory Strategist to develop and implement global regulatory strategies. The role involves leading ... regulatory submissions and ensuring compliance with quality standards. Candidates should have over 10 years of drug development experience and strong communication skills. This position offers an opportunity to make a significant impact on innovative… more
- Gilead Sciences, Inc. (Foster City, CA)
- …biopharmaceutical company seeks an experienced professional to oversee digital modernization of CMC RA platforms in Foster City, California. The role requires strong ... experience in regulatory operations, strategic planning, and change leadership, along with...in chemistry or related fields. The successful candidate will lead workforce capability design and create processes for knowledge… more
- Gilead Sciences, Inc. (Foster City, CA)
- …accountability. As a member of Gilead, you contribute to creating possible, together. KEY RESPONSIBILITIES Lead CMC regulatory strategy for one or more ... guidelines to achieve an approved/harmonized regulatory control strategy . Collaborate across CMC Regulatory ... Affairs, PDM, and other functional groups within Gilead. Lead CMC strategies, assess risks, and develop… more
- Blonde Inc. (Boston, MA)
- Hemab is seeking a Director of Regulatory Affairs, CMC to lead global regulatory strategy across our portfolio of rare disease therapies. This role ... strategies are integrated into development plans and executed effectively. Lead CMC regulatory aspects of health authority interactions, including… more
- Gilead Sciences, Inc. (Foster City, CA)
- …California seeks an Associate Director in CMC Regulatory Affairs to lead regulatory strategy and ensure compliance in biologics development. The ... have over 10 years of experience and proven success in executing CMC strategies. Strong leadership and communication skills are essential. Competitive salary range… more
- Blonde Inc. (Boston, MA)
- …in Boston is seeking a Director of Regulatory Affairs, CMC to lead the global regulatory strategy across a portfolio of rare disease therapies. ... The role involves managing CMC -related regulatory activities, collaborating with cross-functional teams, and ensuring high-quality regulatory submissions.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …partnership with any broader initiatives in this space across the enterprise.* Lead workforce capability design, training strategy , and upskilling initiatives. ... * Oversee digital modernization of core CMC RA platforms (eg, RIM) and integration across...regulatory operations, strategic planning, and operational execution of CMC RA initiatives.* Experience with CMC requirements… more
- Takeda (Boston, MA)
- …will contribute: Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy . Guide the team to define ... and drive strategy for CMC regulatory dossier content and review this...Team lead role, prepares and maintains relevant regulatory documentation (eg, technical regulatory strategy… more
- Taiho Oncology in (Princeton, NJ)
- …( CMC ) documentation for regulatory filings. Experience in developing and implementing CMC regulatory strategy for early and late stage of development ... expanding mid‑size company in the role of Director for Regulatory CMC directly reporting to Executive Director,...will play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life… more
- Valid8 Financial, Inc. (San Francisco, CA)
- … Regulatory Position Summary: The Director/Senior Director, Regulatory Affairs will lead and execute global regulatory strategy and operations to ... Lead the development and implementation of global regulatory strategies for both clinical development and CMC... team for developing strategy and review CMC sections of regulatory submissions (Module 3)… more
- Sanofi (Convent Station, NJ)
- …behaviors that model the Sanofi and GRA Values/Principles/Competencies.* Oversees the development of CMC regulatory strategy and regulatory risk ... landscapes. With a commitment to Sanofi's "Take the Lead " values, particularly in "Leading Together" and "Being Bold,"...with FDA and EMA, so that appropriate and pragmatic Regulatory CMC positions are negotiated with the… more
- Dyne Tx (Waltham, MA)
- …guidance from the team and leadership Lead the development of CMC documentationpertaining toglobal Regulatory filings (IND, IMPD, BLA, etc.) and responses ... Control ( CMC ) is accountable for executing global CMC regulatory strategies for our programs in... regulatory milestones Ability to effectively communicate the regulatory strategy , risks, mitigations, and overall plans… more
- Takeda (Boston, MA)
- …requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post‑market ... support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post‑market support teams. How you… more
- Codexis, Inc. (Redwood City, CA)
- …/ year Description We are seeking an experienced and strategic Associate Director/Director of CMC Regulatory Affairs to lead and execute regulatory ... and/or co-develop Module 3 CMC information for partner submissions. Key Responsibilities Regulatory Strategy & Leadership Develop and implement CMC … more
- Exelixis, Inc. (Alameda, CA)
- …solutions for process optimization and efficiency commensurate with departmental and company growth.* Lead internal preparation of CMC strategy in support of ... DUTIES/RESPONSIBILITIES: Lead development of high quality, phase appropriate CMC -related submissions to regulatory authorities and regulatory … more
- Pattern Biosciences (South San Francisco, CA)
- …Architect Compose and defend all CMC sections of INDs and other regulatory submissions Lead interactions with FDA and other agencies. Translate evolving ATMP ... the biotech or pharmaceutical industry. Primary Responsibilities Set the CMC Vision & Roadmap Translate the product strategy...partners. Serve as the Regulatory CMC … more
- WuXi Biologics Group (Los Angeles, CA)
- …8+ years of applicable work experience. Good knowledge of CMC strategy , risk and resource management, regulatory requirements, and ICH guidelines. Strategic ... WuXi Biologics CMC strategies and recommendations in supporting all ongoing projects in CMC development. Lead CMC projects with a good understanding of… more
- Allergan (Greenlawn, NY)
- …utilizing a matrix approach. You lead Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... member of AST, you have accountability for creating a CMC strategy and development plan that aligns... queries, and participates in communications and meetings with regulatory agencies. Taking accountability for creating CMC … more
- The Antibody Society (Chicago, IL)
- …complexity using a matrix approach. You lead Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... member of AST, you are accountable for creating a CMC strategy and development plan that aligns... queries, and engaging in communications and meetings with regulatory agencies. Leading PPDST and/or CMC development… more
- Allergan (San Francisco, CA)
- …product development across programs, align strategy with clinical and regulatory goals, and lead a global, cross‑functional team. Collaborate with ... thinking, and champion quality and resource management. Develop, update, and implement CMC product development plans while ensuring regulatory , health, safety,… more
