Regulatory Affairs Specialist Jobs in Burlington, MA

Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...

Discover an opportunity to empower energy policy initiatives and drive utility incentives. Join our dynamic team to shape regulatory strategies for geothermal heating, building relationships with stak...

Strategize and lead regulatory strategies for advertising and promotions, ensuring compliance and effectiveness. Work cross-functionally to maximize product impact and navigate complex medical environ...

Unlock your potential as a key player in advertising and promotion compliance, guiding regulatory strategies and collaborating across teams to enhance product success in the pharmaceutical sector. Rea...

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

Help us enhance quality assurance in external manufacturing operations through thorough documentation review, proactive communication, and participation in audits to ensure compliance and product reli...

Join us to lead quality assurance initiatives across GxP operations, driving impactful metrics and analyses. You'll collaborate independently on validations, managing documentation, and ensuring compl...

Transform regulatory strategies in FDA Pharma and IVDR, ensuring compliance and driving product approvals. Collaborate with cross-functional teams, mentor associates, and enhance processes to support...

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...

Shape the future of medical devices by leading regulatory strategies, ensuring compliance across global markets, and mentoring a dedicated team. Empower innovation through effective communication with...

Champion quality assurance initiatives by overseeing product disposition and batch record reviews while driving compliance and continuous improvement in collaboration with cross-functional teams...

Join a team that's driving innovation in R&D and Regulatory processes. Leverage your Veeva RIM expertise, manage global compliance systems, and implement solutions that meet dynamic business needs whi...

Transform regulatory compliance by supporting submissions and documentation, ensuring adherence to standards, and collaborating with teams to navigate evolving regulations in a dynamic environment...

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...

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...

Champion CMC regulatory submissions by authoring high-quality dossiers for radiopharmaceuticals and biopharmaceuticals, ensuring compliance and collaboration across teams throughout the product lifecy...

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...

Join us to lead global CMC regulatory strategies for cell and gene therapy products, ensuring compliance with global regulations while supporting the product lifecycle from development to registration...

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

Transform the regulatory landscape by leading labeling efforts for animal health products, ensuring compliance and excellence throughout the product lifecycle while collaborating with cross-functional...

Join our team to enhance compliance culture, driving quality and safety standards through effective investigations, documentation, and training in a dynamic manufacturing environment. Your expertise w...

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

Transform compliance operations by performing QA tasks to ensure GMP standards are met during clinical trials and production, collaborating with QA, QC, and Manufacturing teams to foster high-quality...

Transform compliance through expertise in HR regulations, policy management, and training. Support a culture of accountability while navigating multi-state employment laws across diverse teams, ensuri...

Oversee quality assurance activities, ensuring compliance and product integrity. Execute QMS processes, manage product complaints, support DSCSA adherence, and collaborate with cross-functional teams...