Director, Regulatory Affairs Jobs in Waltham, MA

Lead the charge in compliance strategy for U.S. Commercial and Market Access. Collaborate with senior leaders to guide complex compliance issues, manage risks, and support innovative business objectiv...

Lead the charge in strategic Regulatory CMC activities for small molecule development, ensuring compliance and successful global submissions while collaborating with diverse teams to foster drug devel...

Elevate your career by leading a high-impact CMC stability function, managing critical stability strategies across non-clinical, clinical, and commercial programs. Collaborate with diverse teams to en...

Grow your legal expertise in patents by leading efforts to protect innovative manufacturing processes in the life sciences. Collaborate with scientists and manage patent strategy to enhance a robust i...

Contribute to strategic medical initiatives in our neurology domain, supporting Migraine-related projects and collaborations. Engage with cross-functional teams, oversee clinical activities, and lead...

Partner with us to drive contract negotiations and legal support, ensuring compliance and efficiency in our research and development processes, while managing external counsel and contracts across var...

Build and lead a dynamic Quality Systems team, driving the strategy and improvement of a scalable Quality Management System to ensure compliance and support innovative biotech operations from clinical...

Join a dynamic team to enhance a top-tier compliance program, partner with cross-functional leaders, and cultivate a culture of integrity and accountability in the pharmaceutical industry. Drive compl...

Join a team that drives clinical safety and compliance by leading Pharmacovigilance initiatives. Oversee safety signal processes, author critical safety reports, and mentor staff to ensure the integri...

Drive your career forward as you manage critical Pharmacovigilance activities, ensuring safety compliance and signal management for clinical trials and products. Collaborate with teams to analyze data...

Join a team that drives quality excellence in the medical device industry. Oversee Quality Management Systems, lead a talented team, and ensure compliance with international regulations while fosterin...

Accelerate your career by leading national access for a groundbreaking cell therapy. Collaborate to educate stakeholders, ensure reimbursement readiness, and facilitate coverage pathways, making a mea...

Shape the future of regulatory affairs by leading global strategy, ensuring compliance, and fostering key agency relationships. Drive product submissions, build high-performing teams, and enhance orga...

Join a team that's shaping the future of Quality Control operations. You will provide strategic leadership and oversight for QC laboratory functions, ensuring high-quality testing services that suppor...

Oversee and enhance compliance across global genetic data collaborations, managing deliverables and governance while leading a team to ensure accountability and transparency in operations and strategi...

Drive regulatory strategy and execution for regional projects. Lead cross-functional teams and ensure compliance through submission management while fostering collaboration with health authorities and...

Empower healthcare professionals with accurate, evidence-based Medical Information. Lead a dynamic team to develop resources and actionable insights, ensuring compliance while supporting product lifec...

Pioneer integrated data review practices, ensuring high-quality clinical data through strategic leadership, oversight, and continuous improvement across clinical programs while driving cross-functiona...

Champion quality excellence by leading oversight of external manufacturing operations to ensure compliance and product integrity while driving strategic partnerships and governance in a dynamic biopha...

Transform quality systems by driving continuous improvement and fostering a culture of excellence. Collaborate across functions to enhance compliance and efficiency, thereby elevating both employee an...

Champion strategic resourcing by analyzing data and leading staffing initiatives. Drive operational efficiency, manage complex workforce demands, and enhance financial performance while fostering grow...

Support strategic workforce planning and resource allocation to enhance operational efficiency. Collaborate with senior leadership to resolve staffing challenges and optimize financial performance thr...

Empower product innovation by leading analytical development and quality control strategies, ensuring compliance and excellence across all stages of biologics development, from early research through...

Lead regulatory strategies for US promotional materials, ensuring compliance with FDA standards while collaborating across departments. Provide expertise for complex products, navigating regulatory la...

Unlock potential by serving as a strategic legal advisor, guiding compliance across the organization. Collaborate with leaders to shape robust compliance programs while safeguarding ethical practices...