1,827 Results for

Regulatory Affairs Jobs in Kenmore, MA

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Associate Director, Commercial Training and Development Amylyx Pharmaceuticals

Cambridge, MA

Remote

Demonstrated experience developing and delivering pharmaceutical or biotechnology training in areas such as disease state, clinical data, product knowledge, selling skills, customer engagement, business acumen, market access, launch readiness, or leadership development. Work closely with Sales Leadership, Marketing, Market Access, Patient Services, Medical Affairs, Commercial Operations, Human Resources, Regulatory, Legal, and Compliance to identify training needs, establish learning priorities, align content, and coordinate delivery.

13 days ago

Associate Director, Commercial Training and Development Amylyx Pharmaceuticals Inc

Cambridge, MA

Remote

$191,000–$215,000 / year

30+ days ago

Vendor Quality Management Manager - Pharma HonorVet Technologies

Boston, MA

$60–$77 / hour
Quick Apply

With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations. HonorVet Technologies (SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States.

30+ days ago

Head of Commercial, US Oncology Les Laboratoires Servier SAS

Boston, MA

$350,000–$450,000 / year

The VP will partner closely with Market Access, Business Excellence, Medical and Patient Affairs, Regulatory Affairs, Manufacturing, Finance, Legal and Compliance, Corporate Affairs and Global Commercial teams to ensure seamless execution of commercial strategy across the product lifecycle. The role will lead over a 100 marketing and sales professionals aligned to the oncology portfolio and will have general management responsibilities including oversight of all brand management, launch activities, and will hold full accountability for the delivery of the P&L of the oncology business.

30+ days ago

Assoc. Director, IT Business Partner - Pharmaceutical Development BioCryst Pharmaceuticals

Boston, North Carolina

Remote

This role serves as a strategic technology advisor and delivery leader, with responsibility for business analysis, program and project leadership, solution design, data and integration strategy, vendor management, adoption, and ongoing application support. · Strong knowledge of business processes and information needs across several of the following areas: Program & Portfolio Management, Clinical Development / Operations, Biometrics, Pharmacology / Non-Clinical, Regulatory, Safety, and Medical Affairs.

30+ days ago

Vice President, Non Clinical Development Stoke Therapeutics, Inc.

Bedford, MA

$349,000–$399,000 / year

Serve as a key pillar of the R&D leadership team, helping define and execute the company's drug development vision and strategy while driving a collaborative, egalitarian culture driven by scientific rigor, excellence, accountability, portfolio focus, and patient impact and defined by kindness and mutual respect. The ideal candidate combines broad scientific expertise and industry perspective with strong organizational leadership and the ability to communicate effectively with executive leadership, regulatory authorities, and cross functional teams.

17 days ago

Associate Director, Global Patient Safety Standards & Training Regeneron Pharmaceuticals

Uxbridge, MA

Discover your role: Ensure that PV Intelligence updates are systematically assessed and reflected in GPS procedures, so that documented processes remain aligned with current regulatory expectations and the procedural framework is maintained in a state of audit and inspection readiness at all times. Maintain an overview of CAPAs associated with procedures, including those arising from both audits and inspections, and work closely with SMEs, PONs and the P&P team to ensure timely CAPA closure, including allowing appropriate time for associated training.

30+ days ago

Executive Medical Director/Clinical Development Lead, GU GSK plc

Waltham, MA

$242,250–$403,750 / year

Clinical Data Interpretation, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Development, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations, Strategic Direction. The CDL owns the clinical roadmap and serves as the recognised clinical authority and visible leader for the asset's strategic vision, shaping how clinical strategy, scientific insight, development innovation, and decision velocity are understood and experienced across the organisation, representing Clinical Development in both internal and external settings.

4 days ago

Senior Medical Director, Oncology Clinical Development - Sarcoma GSK plc

Waltham, MA

$284,250–$473,750 / year

Clinical Data Interpretation, Clinical Pharmacology, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Development, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations, Strategic Direction. Operating within the clinical strategy defined by the Clinical Development Lead (CDL), the Senior Medical Director partners closely with the Senior Scientist and cross-functional teams to guide the integration of physician expertise into study execution and programme-level decision-making.

30+ days ago

Material Compliance Engineer II, Fluid Management Repligen Corporation

Massachusetts

Maintain accurate, organized, and up-to-date compliance documentation and data libraries for raw materials and finished products, including REACH declarations, RoHS certifications, Safety Data Sheets (SDS), material disclosures, regulatory assessments, and related compliance records. Develop and maintain regulatory compliance data repositories and documentation systems to support customer requests, product stewardship activities, supplier data management, and long-term compliance readiness.

6 days ago

Drug Product Process Scientist - Small Molecules Takeda

Boston, Massachusetts

$137,000–$215,270 / year

Expert-level knowledge of drug product process development, commercial manufacturing, process characterization, validation, continued process verification, technology transfer, scale-up, quality risk management, GMP compliance, Regulatory CMC submissions, and lifecycle management. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

16 days ago

Senior Counsel Operations and Pharmacy Legal AbbVie Inc

Waltham, MA

Responsibilities: Serve as a key legal advisor to cross-functional business teams, providing proactive counsel on commercial, regulatory, or operational issues Interpret and apply U.S. laws and global regulations relevant to the pharmaceutical or healthcare environment Review and advise on contracts, business activities, and strategic initiatives to ensure legal compliance and alignment with company objectives. The role will support various Operations stakeholders, including AbbVie's onsite Pharmacy and advise on pharmacy regulatory compliance, controlled substance management, pharmacy licensure matters, as well as commercial contracts requests.

30+ days ago

Director, Clinical Program Quality and Excellence Takeda Pharmaceutical Co Ltd

Boston, MA

$177,000–$278,080 / year

You will partner closely with global cross-functional stakeholders, including Clinical Development, Study Execution Teams, Regulatory Affairs, and Quality organizations, to identify emerging risks, drive issue resolution, and strengthen quality performance across clinical programs. This role is responsible for shaping and executing risk-based quality management strategies across assigned clinical programs, ensuring inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle.

30+ days ago

Drug Product Process Scientist - Small Molecule Takeda Pharmaceutical Co Ltd

Boston, MA

$154,400–$242,550 / year

23 days ago

Associate Director, Bioanalytical Development Formation Bio

Boston, MA; New York

$177,500–$232,000 / year

The Associate Director, Bioanalytical will lead bioanalytical strategy and delivery for assigned programs, working across nonclinical and clinical teams to ensure assays are fit for purpose and support key development decisions. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials.

13 days ago

Associate Director, Regulatory Affairs Seaport Therapeutics

Boston, Massachusetts

Support Phase II PoC & Phase III Readiness; Develop Phase II protocols with Go/No-Go criteria and strategies to de-risk psychiatry/neurology programs; Prepare Phase III regulatory groundwork, including End-of-Phase II (EOP2) meeting packages, safety database planning, and alignment with ICH guidelines for multi-regional trials. Design integrated early development strategic plans that bridge preclinical data (toxicology, pharmacology, CMC) with Phase I/II clinical objectives, addressing unique psychiatry/neurology challenges (e.g., blood-brain barrier delivery, placebo response mitigation).

24 days ago

Senior Clinical Trial Manager MBX Biosciences Inc

Burlington, MA

Our pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism, currently preparing for Phase 3 development, and a growing obesity portfolio that includes MBX 4291 in Phase 1 development, MBX 5765, a next-generation amycretin prodrug designed for once-monthly-dosing, as well as MBX 6180, a GLP/GIP/GCGR triple agonist prodrug for once monthly dosing; all of which optimize our PEP platform. The ideal candidate is a proactive problem solver with strong cross-functional leadership skills, experience managing global and/or multicenter clinical trials, and a passion for driving operational excellence in a fast-paced biotech environment.

30+ days ago

Director Of Financial Aid Benjamin Franklin Cummings Institute of Technology

Boston, MA

$85,000–$105,000 / year

The Director also provides strategic oversight of the College's outsourced financial aid partner (FA Solutions), establishing performance expectations, monitoring service delivery, ensuring contractual compliance, and fostering a collaborative partnership that supports institutional goals and an exceptional student experience. As a key member of the Enrollment Services leadership team, the Director collaborates closely with Admissions, Student Accounts, the Registrar, Student Affairs, Finance, Information Technology, Academic Affairs, and external agencies to remove financial barriers and advance the College's enrollment and student success goals.

30+ days ago

Grants and Research Administrator Babson College

Massachusetts

Monitors cost sharing, sub recipient monitoring, reporting deadlines, award modifications, no-cost extensions, carryforward requests, rebudgeting actions, and other post-award administrative requirements Prepares or coordinates periodic and final financial reports and assists with sponsor reporting requirements. Develops, documents, and continuously improves federal and non-federal post-award operations, procedures, workflows, and internal controls in collaboration with key campus stakeholders and in alignment with Uniform Guidance, sponsor requirements, and College policies.

19 days ago

Corporate Counsel HP Hood

Lynnfield, MA

$165,000–$185,000 / year

This position also will draft, review, and negotiate a broad range of commercial agreements for numerous business teams, including Sales, Procurement, Marketing, Regulatory Affairs, Information Technology, Operations, and other areas of the company. Review consumer-facing materials across traditional, digital, social media, influencer, and e-commerce channels; assess legal risk; and provide practical guidance to business stakeholders.

11 days ago

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Regulatory Affairs Jobs in Kenmore, MA

Associate Director, Commercial Training and Development Amylyx Pharmaceuticals

Associate Director, Commercial Training and Development Amylyx Pharmaceuticals Inc

Vendor Quality Management Manager - Pharma HonorVet Technologies

Head of Commercial, US Oncology Les Laboratoires Servier SAS

Assoc. Director, IT Business Partner - Pharmaceutical Development BioCryst Pharmaceuticals

Vice President, Non Clinical Development Stoke Therapeutics, Inc.

Associate Director, Global Patient Safety Standards & Training Regeneron Pharmaceuticals

Executive Medical Director/Clinical Development Lead, GU GSK plc

Senior Medical Director, Oncology Clinical Development - Sarcoma GSK plc

Material Compliance Engineer II, Fluid Management Repligen Corporation

Drug Product Process Scientist - Small Molecules Takeda

Senior Counsel Operations and Pharmacy Legal AbbVie Inc

Director, Clinical Program Quality and Excellence Takeda Pharmaceutical Co Ltd

Drug Product Process Scientist - Small Molecule Takeda Pharmaceutical Co Ltd

Associate Director, Bioanalytical Development Formation Bio

Associate Director, Regulatory Affairs Seaport Therapeutics

Senior Clinical Trial Manager MBX Biosciences Inc

Director Of Financial Aid Benjamin Franklin Cummings Institute of Technology

Grants and Research Administrator Babson College

Corporate Counsel HP Hood

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