- MannKind Corp. (Burlington, MA)
- …regulatory leadership team and are seeking a strategic, execution‑oriented Associate Director of Regulatory Strategy with a strong foundation in ... CMC, clinical, and operations. Responsibilities Define & Drive Global Strategy : Serve as the global regulatory lead...Drive Global Strategy : Serve as the global regulatory lead for assigned development programs and marketed products,… more
- Alkermes, Inc. (Waltham, MA)
- A leading biopharmaceutical company is seeking an experienced Associate Director for Regulatory Affairs CMC to provide strategic regulatory direction and ... related to a late-stage development program. The role requires expertise in regulatory compliance and the ability to collaborate with cross-functional teams. This… more
- MannKind Corp. (Burlington, MA)
- A biopharmaceutical company is seeking an Associate Director of Regulatory Strategy . The role involves leading regulatory strategy for ... across development stages. Candidates should have a strong background in regulatory affairs, including experience with FDA interactions and global submissions. Ideal… more
- 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
- Real Staffing (Boston, MA)
- …leading staffing organization is seeking an experienced Associate Director of Regulatory Affairs to support regulatory strategy on a contract basis. ... role offers flexible remote or hybrid options and involves leading regulatory submissions and maintaining compliance with global health authorities. Candidates… more
- Codexis, Inc. (Redwood City, CA)
- Associate Director / Director , CMC Regulatory Affairs Department: 58 - Tech Ops Management Employment Type: Full Time Location: Redwood City, CA ... are seeking an experienced and strategic Associate Director / Director of CMC Regulatory Affairs...Module 3 CMC information for partner submissions. Key Responsibilities Regulatory Strategy & Leadership Develop and implement… more
- NWRPros (Palo Alto, CA)
- …gastroesophageal cancers. Our Client is seeking a dynamic and experienced Sr Manager / Associate Director of Regulatory Affairs. The role is responsible for ... ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global … more
- Gilead Sciences, Inc. (Foster City, CA)
- Position Associate Director , CMC Regulatory Affairs - Biologics Overview Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, ... of Gilead, you contribute to creating possible, together. KEY RESPONSIBILITIES Lead CMC regulatory strategy for one or more products. Lead the execution and… more
- AstraZeneca (Boston, MA)
- Job Title: Clinical Regulatory Writing Manager ( Associate Director ) Location: Boston, MA - Hybrid Introduction to role Are you ready to be part of the ... solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory ...efficiency. Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead. Lead… more
- Gilead Sciences, Inc. (Charleston, SC)
- Associate Director , Regulatory Affairs... regulatory agencies. You will manage the commercial regulatory strategy and execution of such for ... and Promotion United States - South Carolina - Charleston Regulatory Regular Regulatory Advertising and Promotion (RA...Requisition ID R0044832 Full Time/Part Time Full-Time Job Level Associate Director Click below to return to… more
- BioNTech IMFS (Cambridge, MA)
- Associate Director , Global Regulatory Affairs Cambridge, US; New Jersey, US | full time | Job ID:9842 Company Summary BioNTech is a Nasdaq listed ... Comirnaty (COVID-19 vaccine) is its first commercialized product. Position Summary The Associate Director , Regulatory Affairs (Advertising and Promotion)… more
- Real Staffing (Boston, MA)
- Job Description: Title: Associate Director , Regulatory Affairs (Contract) Location: Remote or Hybrid Contract Duration: 6-12 months (with potential ... extension) About the Role: We are seeking an experienced Associate Director of Regulatory Affairs...team on a contract basis. This role will support regulatory strategy and execution across development programs,… more
- TANNER & ASSOC INC (Trenton, NJ)
- Associate Director , Regulatory Affairs, Advertising & Promotion-New Jersey Tanner and Associates is recruiting an Associate Director , Regulatory ... Regulatory Manager on International Product Teams to insure that regulatory strategy will result in commercially viable US labeling in which future promotion… more
- Exelixis, Inc. (Alameda, CA)
- Associate Patient Recruitment & Retention Strategy Director page is loaded## Associate Patient Recruitment & Retention Strategy Directorlocations: ... Connect to Cancer Patients! The Associate Patient Recruitment and Retention Strategy Director is involved in executing Exelixis' comprehensive strategy … more
- Crescent Biopharma, Inc. (Waltham, MA)
- …and follow the Company on LinkedIn and X. Position Overview The Associate Director , Regulatory Operations, will oversee the planning, ... goals. Serve as the primary Regulatory Operations Lead, collaborating with Regulatory Strategy to develop and manage submission timelines and processes.… more
- CSL Plasma Inc. (Waltham, MA)
- Associate Director Clinical Assay Strategy Transplant & Immunology and Immunoglobulins X2 page is loaded## Associate Director Clinical Assay ... data sets to meet the business needs. Deep understanding of assay design, regulatory standards and industry best practices are essential. The incumbent will have a… more
- CSL Plasma Inc. (Waltham, MA)
- Associate Director Clinical Assay Strategy , Hematology and Cardiovascular & Renal page is loaded## Associate Director Clinical Assay Strategy , ... data sets to meet the business needs. Deep understanding of assay design, regulatory standards and industry best practices are essential. The incumbent will have a… more
- Biogen, Inc. (San Francisco, CA)
- The Associate Director , Regulatory Affairs will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for ... product development and approval, in alignment with the global business strategy . Responsible for leading a comprehensive and strategic approach to developing and… more
- Dyne Tx (Waltham, MA)
- …and follow us on X, LinkedIn and Facebook. Role Summary The Associate Director , Regulatory Chemistry Manufacturing and Control (CMC) ... program's critical regulatory milestones Ability to effectively communicate the regulatory strategy , risks, mitigations, and overall plans to Project/Program… more
- Gilead Sciences, Inc. (Foster City, CA)
- Associate Director , Social Media Strategy United States - California - Santa Monica, United States - California - Foster City Public Affairs/Communications ... that will improve the lives of patients with life-threatening illnesses worldwide. As the Associate Director , Social Media Strategy ,e ssential duties and… more
