- 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
- 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
- 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
- CSL Plasma Inc. (Waltham, MA)
- A leading biotherapeutics company in Waltham seeks an Associate Director for Clinical Assay Strategy . This role involves developing bioanalytical strategies ... and ensuring compliance with regulatory standards for clinical programs. The successful candidate will have a PhD, over 8 years of industry experience, and proven… 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
- 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
- ClinChoice (Waltham, MA)
- …and ensure high-quality deliverables for regulatory submissions. Role Overview The Associate Director , Programming will serve as a strategic and technical ... Associate Director , Statistical Programming (Permanent) -..., deep knowledge of CDISC standards, and experience supporting regulatory submissions. Key Responsibilities Lead programming strategy … 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
- Madrigalpharma (Waltham, MA)
- Associate Director , Patient Support Solutions page is loaded## Associate Director , Patient Support Solutionslocations: MA - Waltham - Officetime type: ... support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at...right talent, at the right time, in the right way.** Associate Director , Patient Support Solutions**Location: Waltham Department:… 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
- Madrigalpharma (Waltham, MA)
- Associate Director , Integration Engineer About Madrigal: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non‑alcoholic steatohepatitis ... for the treatment of NASH with compensated cirrhosis. Role Overview As the Associate Director of Integration Engineering, reporting to the Senior Director… more
- Cedent Consulting Inc. (Waltham, MA)
- Associate Director / Director , Bioanalytic Development & Operations (Waltham, MA) Responsibilities (including, but not limited to): Lead and oversee the ... subject matter expert and be a team resource for bioanalytical knowledge, strategy and application in drug development Leverage depth of knowledge and hands‑on… more
- Women In Bio (Waltham, MA)
- …Collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and ... In this role you will Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate… more
