Director, Regulatory Affairs Jobs in Waltham, MA

Shape the future of drug development by leading formulation and process innovations for parenteral products. Collaborate across teams to ensure high-quality solutions that advance novel therapies and...

Pioneer regulatory CMC strategies while leading cross-functional teams in the pharmaceutical industry. This role will focus on lifecycle management and submissions across US, CA, and EU markets, ensur...

Advance regulatory strategy and submissions for CMC in pharmaceuticals, collaborating with cross-functional teams to ensure compliance with FDA, EMA, and ICH standards while overseeing product lifecyc...

Lead IT Quality and Compliance initiatives for regulated clinical systems. Collaborate with diverse teams, ensuring compliance with FDA and EU standards while driving operational efficiency and suppor...

Shape the future of biotechnology by leading critical commercialization initiatives. Drive cross-functional collaboration, manage complex projects, and streamline execution for successful product laun...

Unlock legal expertise within biopharma and healthcare, tackling clinical trial, regulatory, and data privacy matters. Collaborate across teams to manage risks while driving innovation in research and...

Drive innovation in commercial distribution operations, ensuring efficient partner management, regulatory compliance, and effective integration within the order-to-cash process while leading a dedicat...

Transform the landscape of clinical and regulatory documentation by leading a dedicated Medical Writing department, enhancing quality and compliance through expert leadership and collaboration with cr...

Join our team to lead clinical supply chain strategies, mentor staff, and ensure timely delivery of clinical trial materials all while improving processes and systems for a dynamic and growing environ...

Accelerate program implementation and stakeholder engagement in pharmaceutical market access. Oversee daily operations, client relations, and staff management while ensuring adherence to budgets and p...

Shape the future of Quality Control by leading strategy and compliance initiatives that drive GMP adherence and quality excellence throughout product lifecycles, ensuring collaboration across manufact...

Join a team that's driving innovative cancer research by conducting in vivo studies, utilizing advanced cell-based assays, and collaborating within multidisciplinary groups to streamline drug discover...

Lead the charge in clinical data management to ensure high-quality, analysis-ready data across all stages of clinical studies. Engage in strategic oversight of data collection and analysis, optimizing...

Drive the efficient operations of the analytical testing laboratory, ensuring compliance with quality standards while mentoring a high-performing team. Utilize Lean methodologies to optimize workflows...

Transform your career by leading the technical and operational aspects of a state-of-the-art manufacturing facility, ensuring compliance and reliability while driving successful transitions from const...

Drive analytical development strategies for small molecules from research to commercialization. Lead method development, QC oversight, and cross-functional collaboration in the fast-paced biotech envi...

Shape the future of biopharmaceutical launches by leading global Launch Excellence initiatives, driving operational excellence, and fostering collaboration across diverse teams to enhance launch readi...

Help us lead critical Clinical Pharmacology initiatives, driving drug development strategies and influencing cross-functional teams to enhance project outcomes and departmental objectives. Leverage yo...

Lead and inspire a national field medical team focused on Neurology, fostering relationships with thought leaders and aligning cross-functional strategies for impactful medical affairs outcomes...

Champion compliance and innovation in sterility assurance, collaborating cross-functionally to support regulatory mandates and ensure product safety and efficacy through sterilization processes in man...

Champion innovative safety science strategies, leading comprehensive safety surveillance and risk management efforts across clinical and post-approval landscapes to enhance data integrity and regulato...

Collaborate with senior leaders to build and maintain a strong IP portfolio, supporting R&D and commercialization of biologics products while addressing patent issues and strategies across major marke...

Unlock potential by leading clinical reimbursement strategies across skilled nursing facilities, ensuring compliance and optimal performance through collaboration with multidisciplinary teams to enhan...

Launch a new compliance program supporting government contracts and grants. Drive policy development, training, and monitoring, while ensuring compliance with evolving regulations. Partner with teams...

Drive impactful patient care by leading and developing a high-performing team of Regional Account Managers. Translate strategies into local execution while fostering collaboration and ensuring excepti...