- Crescent Biopharma, Inc. (Waltham, MA)
- …www.crescentbiopharma.com and follow the Company on LinkedIn and X. Position Overview The Associate Director , Regulatory Operations , will oversee the ... objectives and regulatory requirements. Responsibilities Establish and execute Regulatory Operations strategies aligned with company goals. Serve as… more
- Crescent Biopharma, Inc. (Waltham, MA)
- A biopharma company in Waltham, Massachusetts, is seeking an Associate Director of Regulatory Operations . This role is pivotal for managing regulatory ... The ideal candidate will have at least 8 years of experience in regulatory operations , with expertise in the eCTD submission process and tools like DocuBridge… more
- MannKind Corp. (Burlington, MA)
- …growing our regulatory leadership team and are seeking a strategic, execution‑oriented Associate Director of Regulatory Strategy with a strong foundation ... regulatory requirements. Collaborate Cross-Functionally : Partner with Technical Operations , Quality, Clinical, and Commercial functions to proactively identify… more
- Comforcehealth (Bedford, MA)
- Associate Director , Quality Assurance Operations - Healthcare & Research Job ID: 1007606 | Location: Bedford, MA | Contract - 3+ months Job Description ... Associate Director , Quality Assurance Operations ...the systems/processes are deployed effectively. Qualifications Excellent technical and regulatory understanding of downstream drug substance purification processes. Strong… more
- Dyne Tx (Waltham, MA)
- …and follow us on X, LinkedIn and Facebook. Role Summary The Associate Director , Regulatory Chemistry Manufacturing and Control (CMC) ... efforts, as applicable. This position partners with the manufacturing team, clinical operations , quality, other regulatory team members, and program teams. This… 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
- 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) -...Cross‑Functional Collaboration Partner closely with Biostatistics, Data Management, Clinical Operations , and Regulatory teams. Serve as a… more
- Cedent Consulting Inc. (Waltham, MA)
- Associate Director / Director , Bioanalytic Development & Operations (Waltham, MA) Responsibilities (including, but not limited to): Lead and oversee the ... bioanalytical reports or summary sections for preclinical/non‑clinical/clinical reports, and regulatory documents for initiation of clinical studies (such as IND… more
- Apex Systems (Waltham, MA)
- ## Job Description# Associate Director , Safety Systems* Manage Safety Systems user access, configuration updates, testing, and documentation.* Lead validation, ... gateways, E2B profiles, and troubleshoot transmission issues.* Collaborate with PV Operations , Regulatory Affairs, and Quality Assurance to ensure compliance… 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
- Vertex Pharmaceuticals (Boston, MA)
- Privacy Ops & Assurance Associate Director page is loaded## Privacy Ops & Assurance Associate Directorlocations: Boston, MAtime type: Full timeposted on: ... and solutions-oriented advice to a broad spectrum of internal clients on worldwide regulatory issues related to the processing of personal data, including but not… more
- Charles River Community Health (Boston, MA)
- Associate Director of Risk and Compliance Associate Director of Risk and Compliance CLASSIFICATION/STATUS: Full time (would consider part time hours for ... comprehensive, integrated, and equitable primary healthcare that matters most to them. The Associate Director of Risk and Compliance will lead compliance related… more
- Vertex Pharmaceuticals (Boston, MA)
- Commercial Supply Chain Associate Director page is loaded## Commercial Supply Chain Associate Directorlocations: Boston, MAtime type: Full timeposted on: ... Summary:**This role will lead and drive the Sales and Operations Planning (S&OP) process for Casgevy, a commercially launched...capacity to meet both short- and long-term requirements. The Associate Director will be responsible for working… 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
- Vertex Pharmaceuticals (Boston, MA)
- **Job Description**The Associate Director is recognized as an expert in the principles and application of quality and regulatory compliance. The individual ... Commercial Release and serves as primary QA contact on cross-functional teams. The Associate Director manages and develops personnel and support department and… more
- Scorpion Therapeutics (Boston, MA)
- …it, we think you will too! Try it now - JobsAI. Role Summary The Associate Director , Field Operations & Reimbursement supports operational excellence for ... teams, field training, Heme and Diabetes commercial business units, and marketing operations for these activities. Serves as project manager for all above activities… 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 ... This role will lead and drive the Sales and Operations Planning (S&OP) process for Casgevy, a commercially launched...the S&OP process and identifying areas for improvement. The Associate Director will use the dynamic capacity… more
- Vertex Pharmaceuticals (Boston, MA)
- **Job Description General Summary:**The Associate Director , GMP Operational Quality is an advanced technical resource in the principles and application of ... readiness activities and lead Quality development discussions as necessary during regulatory site inspections.* Support review of regulatory submissions, as… more
- Pharmaessentia Corporation (Boston, MA)
- …Position Overview Reporting to the Head of PEC Academy, the Associate Director , Commercial Training supports sales effectiveness through state‑of‑the‑art ... the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the US, Japan, Singapore, South Korea, and China, along with a… more
- Takeda (Boston, MA)
- Job Description Associate Director , In Vivo Digital Portfolio & Data Stewardship About the Role We are seeking an experienced Associate Director of In ... operations , and technology-ensuring seamless integration of study workflows, regulatory compliance, and data interoperability across platforms. The successful… more
