- 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
- 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
- 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
- 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
- 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
- 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
- Takeda (Boston, MA)
- …regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Associate Director will be responsible for complex or highly ... tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory… more
- AstraZeneca (Boston, MA)
- …us in our unique and ambitious world. This is what you will do: The Associate Director , Patient Services Strategy , Rare Hematology/Nephrology will drive the ... portfolio Collaborate closely with the Rare Hematology/Nephrology Patient Services Strategy counterpart Coordinate and deliver the Patient Services brand plans… 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
- 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
- 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
- Galderma Pharma SA (Boston, MA)
- …the company. Reporting into the Executive Director , HCP Engagement and Strategy , this ** Associate Director of Marketing, Therapeutic Dermatology** role ... Associate Director of Marketing, Therapeutic Dermatology...the success of AKLIEF, including developing the HCP marketing strategy and end-to-end execution of prioritized initiatives. **Key Responsibilities:… more
- Madrigalpharma (Waltham, MA)
- Associate Director , Regulatory Affairs, Advertising and Promotion page is loaded ** Associate Director , Regulatory Affairs, Advertising and ... in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.The Associate Director , Regulatory Affairs, Advertising and Promotion is responsible… more
- Vertex Pharmaceuticals (Boston, MA)
- Commercial Supply Chain Associate Director page is loaded## Commercial Supply Chain Associate Directorlocations: Boston, MAtime type: Full timeposted on: ... assumptions, demand and capacity to meet both short- and long-term requirements. The Associate Director will be responsible for working with the commercial team… more
- Galderma Pharma SA (Boston, MA)
- Associate Director , Digital Field Enablement page is loaded## Associate Director , Digital Field Enablementlocations: Bostontime type: Full timeposted on: ... new and challenging work experiences and create an unparalleled, direct impact.The Associate Director , Field Digital Enablement is a senior leader responsible… more
- Takeda (Boston, MA)
- …true to the best of my knowledge. Job Description About the role: The Associate Director , Clinical & Quality Process Compliance is responsible for ensuring the ... and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's… more
- The Association of Technology, Management and Applied… (Boston, MA)
- …assumptions, demand and capacity to meet both short- and long-term requirements. The Associate Director will be responsible for working with the commercial team ... to align capacity assumptions, Finance, Materials, Quality Control and Regulatory that will culminate in the monthly S&OP process....the S&OP process and identifying areas for improvement. The Associate Director will use the dynamic capacity… more
- Thyroxine SERB (Boston, MA)
- …medicine; we're improving the standard of care for more patients around the world. Associate Director , Marketing Overview This role can be based in Philadelphia ... Medicine Head of Marketing. Responsibilities Develop and execute a data-driven brand strategy that drives brand growth and is aligned to overall brand objectives… more
