Senior Regulatory Affairs Specialist Jobs in Princeton, NJ

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...

Manage the creation and publishing of regulatory documents to ensure compliance with Health Authority requirements while coordinating eCTD modules and advising on best practices in document management...

Shape your career by leading the regulatory strategy for critical global products. Collaborate with cross-functional teams to ensure compliance and successful submissions while managing asset developm...

Drive your career with us as a Senior Technical Specialist, where you will enhance Sample Management processes, lead cross-functional projects, and collaborate with experts to deliver high-quality sol...

Champion effective Sample Management by leading process improvements, collaborating across teams, and providing technical expertise to ensure high-quality service delivery and operational efficiency i...

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...

Grow your career with a pivotal role leading comprehensive testing strategies for innovative combination products, ensuring quality and compliance throughout the product life cycle, while collaboratin...

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...

Elevate the quality assurance landscape by leading sponsor-side oversight of CMOs through all stages of manufacturing. Drive excellence in compliance, process validation, and regulatory submissions, e...

Partner with us to enhance supplier quality management in a GMP environment. This role involves qualification, monitoring, and continuous improvement of supplier performance to ensure compliance and o...

Join a team that's central to shaping regulatory CMC strategies and timelines for pharmaceutical products, ensuring compliance with global standards while collaborating cross-functionally to drive pro...

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 managing global regulatory submissions and strategies, ensuring alignment with health authority requirements. Collaborate across teams to drive innovative treatments from concept t...

Drive regulatory excellence by managing global submissions and overseeing interactions with health authorities, ensuring compliance throughout the product lifecycle for various therapeutic areas, prim...

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...

Shape the future of regulatory affairs by leading original ANDA submissions for complex generics, collaborating with cross-functional teams to ensure compliance, accuracy, and timely submission of reg...

Drive regulatory excellence in product innovation, ensuring compliance and safety while empowering creativity and strategy across teams in a dynamic, collaborative environment. Be the key connector be...

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...

Champion regulatory excellence by managing eCTD submissions and ensuring compliance with FDA requirements. Collaborate across teams to maintain documentation standards and training while upholding the...

Join a team that's pioneering innovative CMC regulatory strategies for biologics and pharmaceuticals, managing submissions, and providing strategic client support through all stages of drug developmen...