Regulatory Affairs Manager Jobs in Cambridge, MA

Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...

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

Drive regulatory success by managing complex submissions globally, ensuring compliance with diverse requirements. Collaborate with cross-functional teams to guide product development and maintain up-t...

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...

Shape compliance strategies across hardware and biotech sectors, ensuring products meet global regulatory standards and collaborating with cross-functional teams to drive innovative solutions and main...

Unlock potential by guiding global regulatory strategies for innovative AI/ML healthcare solutions. Collaborate cross-functionally to navigate complex regulations while balancing innovation and patien...

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

Join a dynamic team as a Regulatory CMC Senior Manager, driving global regulatory strategies, lifecycle management, and cross-functional collaboration to advance innovative products in a fast-paced en...

Unlock potential by leading regulatory strategy for clinical gene therapy programs. This execution-focused role drives submissions and health authority interactions while collaborating across cross-fu...

Lead compliance and regulatory activities for medical devices, ensuring adherence to FDA and international standards while managing risk assessments and product recalls. Collaborate cross-functionally...

Drive compliance and regulatory strategy by evaluating product changes, managing post-market activities, and coordinating across departments to ensure adherence to global regulations, supporting safet...

Contribute to regulatory CMC strategies for drug development and commercialization. Lead global submissions, ensure compliance with health authority standards, and engage cross-functional teams for ri...

Join a dedicated team driving global regulatory strategy for early-stage oncology products. You'll execute and manage high-quality submissions and collaborate across functions to ensure compliance and...

Elevate your career by acting as a global regulatory advisor in the agriculture sector. Collaborate and provide strategic insights to ensure compliance, support innovation, and manage stakeholder rela...

Join a team that's shaping the future of global regulatory strategy. Your expertise will drive compliance, oversee submissions, and lead a dynamic regulatory team in executing key strategies for produ...

Execute regulatory strategies for global product approvals, guiding teams through the lifecycle and managing submissions. Foster agency relationships, maintain compliance, and lead audits while mentor...

Champion regulatory strategies and compliance for innovative urology solutions, supporting product development and external partnerships across global markets, enhancing patient care through collabora...

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...

Serve as a strategic leader in Clinical Quality Assurance, overseeing global Pharmacovigilance Quality Systems. Drive continuous improvement initiatives and provide compliance oversight, partnering wi...

Lead the charge in ensuring regulatory compliance for promotional materials. Collaborate cross-functionally to interpret FDA guidelines, mentor staff, and drive effective strategies in advertising for...

Take ownership of a critical pipeline initiative, driving qualified study opportunities via strategic account-based marketing and cross-functional collaboration, focused on delivering real-world evide...

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...

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

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...

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...