Senior Regulatory Affairs Specialist Jobs in Westford, MA

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...

Drive QA support for manufacturing and analytical operations, ensuring compliance and high standards. Review documentation, support batch release, and engage in audits to maintain quality assurance in...

Champion quality and compliance standards as a strategic leader. Lead a team to enhance service delivery, engage in business development, and foster cross-functional expertise within the life sciences...

Join a team dedicated to ensuring drug quality compliance by performing data integrity audits, assessing adherence to FDA standards, and providing actionable recommendations to enhance regulatory deci...

Join us to lead regulatory review of promotional materials, ensuring compliance with FDA regulations. Collaborate with cross-functional teams to enhance product messaging and contribute to the success...

Champion regulatory compliance by managing global submissions, ensuring adherence to laws and guidelines. Collaborate across teams to develop strategies, optimize processes, and maintain effective age...

Unlock potential by ensuring compliance with GMP regulations and quality standards. Collaborate with cross-functional teams to support quality events, tracking metrics, and inspection readiness while...

Join us to shape global Regulatory CMC strategies, driving late-stage development and regulatory submissions across various programs while building a robust function to meet evolving compliance needs...

Create and implement strategic regulatory initiatives for global drug development in a dynamic team environment, ensuring compliance and effective cross-functional collaboration within the biotechnolo...

Join our team to lead regulatory strategies across major programs, driving impactful submissions and fostering collaboration within a challenging and dynamic environment. Embrace the opportunity to in...

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...

Shape the future of regulatory strategy by leading cross-functional teams, driving innovative development strategies, and providing regulatory thought leadership to ensure compliance and accelerate pr...

Lead the charge in developing global regulatory strategies for clinical programs. Manage regulatory operations for product lifecycle while collaborating with cross-functional teams to ensure successfu...

Engage in independent QA oversight across Quality Systems to ensure compliance in commercial manufacturing. Utilize your technical expertise to analyze risks, support quality initiatives, and collabor...

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...

Collaborate with cross-functional teams to oversee regulatory activities for a portfolio of Pharmaceutical Diagnostics products, ensuring compliance and strategic alignment with global standards throu...

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...

Lead global regulatory strategies for oncology programs, ensuring compliance and effectively interacting with regulatory agencies for product approvals in late-stage development...

Join a team that's advancing regulatory strategies for drug substance manufacturing. Lead the charge in selecting and justifying Regulatory Starting Materials, ensuring compliance with global guidelin...

Unlock potential by driving regulatory submissions and managing documentation. Collaborate with global teams to align on strategies, ensuring compliance and effective communication while fostering a c...

Lead global strategy for Notified Body engagement, ensuring compliance, managing audits, and driving certification readiness across various jurisdictions. Guide integration assessments, enhance proces...

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

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...

Take ownership of regulatory strategies and submissions for cutting-edge companion diagnostics. Lead a team while interfacing with cross-functional groups and regulatory authorities to navigate the ap...