Director, Regulatory Affairs Jobs in Boston, MA

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...

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...

Innovate and lead regulatory strategy for transformative gene therapies, shaping FDA and EU interactions. Collaborate cross-functionally to ensure compliance and accelerate patient access through exce...

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 provides strategic legal counsel, ensuring compliance and risk management for R&D initiatives across the Americas. Collaborate with diverse stakeholders to address emerging legal comp...

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...

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...

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...

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...

Join a dynamic team as you drive regulatory strategies and ensure compliance in post-approval activities for CMC processes. Collaborate cross-functionally, influencing clinical outcomes and advancing...

Manage global regulatory strategies for clinical and commercial product registrations. Ensure compliance and successful market access for the PSMA franchise. Lead cross-functional collaborations and d...

Lead the development and execution of global CMC regulatory strategies, ensuring compliance from discovery through commercialization. Collaborate with cross-functional teams to address regulatory requ...

Drive regulatory strategies and oversee compliance for investigational therapies. Work cross-functionally to ensure timely regulatory filings and maintain vendor relationships, contributing to clinica...

Lead the charge in developing and executing CMC regulatory strategies for international submissions, ensuring compliance and guiding teams through complex regulatory landscapes in a dynamic, results-d...

Join a global team to shape regulatory strategies in biotechnology, supporting product development and lifecycle management in Inflammation and Rare Diseases. Lead regulatory efforts, ensure complianc...