Senior Regulatory Affairs Specialist Jobs in Boston, MA

Shape the future of health technology by driving regulatory strategies for innovative lab testing, imaging, and AI products. Collaborate with cross-functional teams to ensure compliance and accelerate...

Join a team that's advancing global health by supporting critical clinical trial submissions. In this role, you'll lead regulatory strategies, ensure compliance, and collaborate with diverse teams to...

Drive regulatory intelligence initiatives to ensure compliance and support clinical research. Collaborate with experts to assess regulatory changes, track global guidelines, and enhance impact assessm...

Champion regulatory strategies to accelerate product approvals and compliance. Lead a dynamic team in supporting innovative medical devices, ensuring alignment with global regulations while fostering...

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...

Transform the future of healthcare by coordinating regulatory submissions and strategies for innovative medical devices, ensuring compliance and supporting product lifecycle management in a dynamic en...

Drive success in regulatory affairs by preparing critical submissions for medical and diagnostic devices. Oversee compliance with U.S. and international regulations while collaborating with cross-func...

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...

Transform regulatory strategies for rare disease and cardio-pulmonary drug-device programs. Collaborate with cross-functional teams to ensure compliance and drive successful submissions globally, supp...

Transform regulatory strategies for combination devices and pharmaceuticals, ensuring compliance with FDA and global standards. Lead complex submissions and collaborate across teams to drive successfu...

Lead the charge in global regulatory strategy for a late-stage immunology program, driving FDA interactions, submissions, and cross-functional decisions while shaping regulatory infrastructure in a dy...

Lead the charge in managing pre-market regulatory activities to ensure compliance with US FDA, Health Canada, and EU IVD regulations. Collaborate with design teams, prepare submissions, and review pro...

Lead the charge in regulatory consulting by delivering expert advice and strategies for clients navigating US, EU, and UK regulations. Manage projects independently, build client relationships, and me...

Transform regulatory strategies by providing CMC expertise to support product development and compliance in a dynamic pharmaceutical environment, ensuring quality and adherence to global standards thr...

Champion regulatory excellence by guiding product development teams, ensuring compliance with global standards, and fostering strong stakeholder relationships to drive business success...

Innovate regulatory operations by managing submission preparation and execution, ensuring compliance with FDA and ICH standards. Collaborate cross-functionally to support complex filings and maintain...

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...

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...

Drive regulatory strategy for early programs, leading cross-functional teams to ensure timely submissions to health agencies. Collaborate with global leads to navigate complex regulatory landscapes an...

Empower innovation by leading regulatory strategies for product launches and compliance. Drive excellence in cross-functional collaboration, ensuring timely approvals and market readiness for orthopae...

Champion global labeling strategy for innovative therapies, leading complex initiatives from development to post-approval. Collaborate with cross-functional teams to ensure compliance and high-quality...

Partner with us to drive regulatory compliance strategies that support innovative therapies. Collaborate cross-functionally to ensure timely submissions and adherence to regulations while enhancing op...

Transform the regulatory landscape by providing strategic leadership in a dynamic biotechnology environment. Collaborate with cross-functional teams to drive innovative RNA-based therapeutic developme...

Empower regulatory excellence by guiding cross-functional teams in compliance and strategy. Leverage deep FDA knowledge to influence promotional materials and ensure adherence to evolving regulations...

Champion regulatory strategy and submissions for clinical-stage radiopharmaceutical programs. Collaborate cross-functionally to ensure compliance and quality in regulatory communications, while leadin...