Senior Regulatory Affairs Specialist Jobs in Burlington, MA

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...

Join a dynamic team and take ownership of regulatory activities for various pharmaceutical products, providing guidance and ensuring compliance while collaborating with cross-functional teams across N...

Optimize regulatory strategies and compliance globally by leading cross-functional projects, guiding teams, and liaising with health authorities throughout the drug development lifecycle to ensure suc...

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...

Pioneer in quality assurance by fostering supplier relationships, leading audits, and driving continuous improvement. Collaborate with teams to enhance supplier performance and mitigate risks while en...

Unlock potential by leading global regulatory CMC activities, developing strategies for product lifecycle management, and collaborating across teams to ensure successful agency submissions. Drive tran...

Architect innovative regulatory strategies for CMC in cell therapy, guiding teams and leading submissions throughout product development, ensuring compliance and successful health authority interactio...

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

Join a team that's committed to sustainable practices and regulatory compliance. This role plays a vital part in ensuring products meet environmental standards while collaborating across functions for...

Champion compliance and innovation in sterility assurance, collaborating cross-functionally to support regulatory mandates and ensure product safety and efficacy through sterilization processes in man...

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...

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...

Lead regulatory compliance programs ensuring inspection readiness and proactive risk management across cross-functional teams. Monitor compliance health, manage data quality, and drive improvements al...

Transform quality systems by enhancing compliance, managing documentation, and supporting vendor activities in a collaborative QA team focused on clinical candidates. Contribute to process improvement...

Tackle regulatory challenges by overseeing compliance of promotional materials, advising on advertising strategies, and managing interactions with the FDA. Drive regulatory initiatives, ensuring align...

Serve as a key resource in regulatory affairs, managing compliance for advertising, promotional materials, and product labeling. Lead interactions with regulatory authorities while ensuring alignment...

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

Drive compliance and quality in GxP software and equipment through assessments, documentation, and vendor oversight. Collaborate with cross-functional teams to ensure reliable inputs and maintain insp...

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...

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...

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...

Elevate the regulatory landscape by guiding strategic promotional communications for Oncology products. Shape impactful messaging while ensuring compliance and aligning with evolving regulations and F...

Take ownership of regulatory advertising and promotion strategies, ensuring compliance with FDA requirements and alignment with corporate goals. Lead cross-functional collaborations in a fast-paced, d...

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...

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...