Director, Regulatory Affairs Jobs in Waltham, MA

Elevate regulatory compliance by leading enterprise surveillance programs, driving governance, and coordinating health authority engagements. Foster a culture of quality and proactive inspection readi...

Lead strategic medical affairs initiatives, engaging cross-functional teams and external stakeholders to advance innovative therapies through clinical phases while ensuring compliance and scientific i...

Partner with us to drive strategic healthcare marketing initiatives. Lead client relationships, oversee peer-to-peer programs, and mentor team members to ensure compliance and achieve results while fo...

Transform the informed consent process by ensuring compliance and precision in consent form development. Collaborate with various stakeholders and mentor new editors, while contributing to quality con...

Drive strategic brand management and execution for franchise products, guiding product lifecycle stages, from launch readiness to phase-out, while leveraging market insights to optimize revenue and en...

Optimize quality assurance processes to ensure compliance with regulatory standards and drive improvements across all operations. Lead a talented team to establish and maintain an effective Quality Ma...

Unlock potential by shaping global market access strategies to optimize pricing and reimbursement for pipeline assets. Collaborate across teams to ensure robust evidence generation and drive strategic...

Join a team that's dedicated to enhancing quality assurance in cell therapy. You will oversee compliance activities across vendors, strengthen quality systems, and drive a culture of continuous improv...

Help us drive growth and engagement in provider partnerships. Lead strategy, operations, and relationship management for our provider relations team, ensuring alignment with organizational goals and e...

Lead the charge in developing and scaling innovative drug substance processes to drive product commercialization. Oversee a team of 30+ scientists and engineers, ensuring efficiency, safety, and excel...

Join a team that redefines evidence generation in rare diseases by leading global real-world evidence initiatives, driving strategic partnerships and overseeing high-impact research to support innovat...

Unlock potential by leading legal transactions in a dynamic life sciences environment. Collaborate cross-functionally to provide strategic advice on complex R&D and commercial contracts, supporting th...

Elevate clinical trial management by leading teams, standardizing processes, and enhancing compliance. Drive operational excellence and integration while ensuring timely, high-quality delivery across...

Unlock potential by shaping global regulatory strategies and driving advocacy initiatives. Collaborate across teams to manage regulatory risks, assess opportunities, and provide strategic insights tha...

Join us to drive strategic clinical FSP partnerships, overseeing delivery and client relationships while managing complex stakeholder environments to enhance operational effectiveness and achieve outs...

Shape strategic growth in bioanalytical services through client acquisition, leveraging expertise in biologics and biomarkers while leading national business development efforts to expand presence in...

Join a team that's pioneering quality assurance in medical device design. Lead a talented quality organization, ensuring product compliance and safety while driving continuous improvement across desig...

Lead the charge in regional compliance for Good Pharmacovigilance Practices by managing inspection readiness, driving improvements, and fostering a culture of patient safety across international stake...

Partner with us to support business growth as a Corporate Counsel in the biotech industry. Engage in contract drafting, negotiation, and compliance, collaborating with cross-functional teams in a fast...

Lead and manage clinical trial operations, ensuring quality, timelines, and budget goals are met. Champion the development of a high-performing team while collaborating across departments to drive suc...

Partner with us to innovate and transform Quality & Regulatory operations through technology and data analytics. Drive automation, improve efficiency, and foster effective digital solutions that enhan...

Elevate drug development by providing expert reproductive toxicology guidance across multidisciplinary teams, shaping safety strategies, and supporting regulatory interactions to ensure product safety...

Shape the future of pharmacology by executing in vivo studies and collaborating with a cross-functional team. Contribute to cutting-edge research that impacts drug development and platform advancement...

Drive compliance excellence by managing vendor quality, conducting technical investigations, and optimizing quality management systems. Collaborate across functions to ensure timely resolutions and co...

Grow your expertise in regulatory affairs by providing essential support and guidance on the 340B Drug Pricing Program. Collaborate across teams to align compliance initiatives, drive operational exce...