Director, Regulatory Affairs Jobs in Cambridge, MA

Engage in dynamic regulatory project management, driving success for biotech clients. Oversee diverse projects, ensure timely submissions, and foster client relationships while contributing to strateg...

Lead the development of global regulatory strategies and ensure compliance throughout the product lifecycle, from pre-approval to post-approval, as a strategic partner and advisor to cross-functional...

Take ownership of IMP labeling processes, ensuring compliance with global regulations and quality standards while collaborating cross-functionally to support clinical trial timelines and enhance label...

Shape the future of product communication by delivering expert regulatory guidance, collaborating across departments, and ensuring compliance with FDA regulations to support brand initiatives and prom...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Manage regulatory strategies for AI-enabled medical imaging software, ensuring compliance across FDA and EU markets. Collaborate with cross-functional teams to facilitate submissions and lifecycle man...

Shape the future of pharmaceutical development by leading regulatory CMC strategies to support investigational and post-approval product success. Collaborate with cross-functional teams to ensure comp...

Unlock potential by shaping global regulatory strategies that enable successful product launches. Collaborate across functions to ensure compliance and lead innovative submission processes throughout...

Take ownership of regulatory support for pharmaceutical programs, managing IND and NDA submissions, health authority interactions, and lifecycle maintenance. Collaborate with cross-functional teams to...

Lead the charge in shaping global regulatory strategies for innovative gene therapies, ensuring compliance and successful submissions while mentoring a high-performing team in a dynamic environment...

Elevate your career by providing strategic regulatory leadership in a dynamic biotechnology environment. Collaborate with cross-functional teams to drive innovative RNA-based therapeutics from develop...

Advance regulatory compliance for medical devices, coordinating submissions and strategies across international markets to ensure quality and efficiency in product development and partnerships...

Join a team that's committed to driving innovative regulatory projects, ensuring compliance, and collaborating with cross-functional teams to secure timely submissions and approvals for products in th...

Lead regulatory strategy and execution for IVD products, ensuring compliance and successful submissions. Collaborate across teams to shape development plans and manage regulatory risks, driving projec...

Oversee regulatory compliance operations, ensuring adherence to laws and regulations for assigned products/services while collaborating across departments to implement effective compliance strategies...

Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...

Shape the future of regulatory technology by leading strategic initiatives that enhance compliance, efficiency, and insight-driven operations across Regulatory Affairs and Medical Writing, ensuring se...

Lead regulatory strategy for clinical-stage radiopharmaceuticals, ensuring compliance and effective health authority engagement. This pivotal role demands substantial experience in biotech regulations...

Elevate regulatory project management by leading cross-functional teams to ensure timely execution of complex pharmaceutical and medical device initiatives, aligning with global regulatory standards a...

Lead complex global regulatory project management activities, ensuring alignment across functions and successful submission milestones. Drive operational excellence and best practices to support a gro...

Optimize global regulatory strategies to secure market approval for neuroscience products. Lead cross-functional teams, anticipate regulatory risks, and ensure compliance while managing projects throu...

Help us shape the future of regulatory compliance by supporting submissions, approvals, and post-launch activities. Engage with cross-functional teams to ensure adherence to guidelines while managing...

Transform regulatory strategy and operations across CMC and clinical activities, leading a high-performing team to ensure compliance and successful product approvals from development through post-appr...

Unlock potential by leading regulatory compliance for advertising and promotional materials, guiding cross-functional teams in strategic initiatives, and ensuring adherence to industry standards and F...

Lead the charge in developing regulatory strategies for managed access programs, guiding clients through global pathways, and enhancing patient access to investigational therapies through strategic in...