Senior Regulatory Affairs Specialist Jobs in Madison, NJ

Advance regulatory compliance as a key member of a collaborative team, ensuring timely solutions for product registration and commercialization. Solve complex challenges and foster innovation while sa...

Lead the development and execution of global CMC regulatory strategies to support clinical asset advancement. Collaborate cross-functionally to ensure timely, high-quality submissions and health autho...

Lead the charge in optimizing clinical trial operations, ensuring compliance and data integrity across multiple sites. Collaborate with investigators and cross-functional teams to enhance trial qualit...

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...

Oversee compliance with regulatory standards for advertising across communication channels, collaborating with cross-functional teams to provide strategic guidance and training. Ensure alignment with...

Elevate medical affairs through expert coordination and strategic collaboration in investigator-initiated research, medical education, and post-market activities to enhance compliance and internal ope...

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...

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

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...

Architect global fragrance compliance strategies by interpreting regulatory frameworks, driving adherence to IFRA standards, and advising teams on risk management. Lead initiatives that anticipate reg...

Drive regulatory excellence as a CMC Lead for innovative bio-conjugate programs. Ensure compliance and oversee milestones from development to post-approval, integrating strategies for complex syntheti...

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...

Join a team that's dedicated to ensuring global regulatory compliance and enhancing quality management. Contribute to medical device approvals and improve processes while gaining ownership of quality...

Contribute to global regulatory compliance while enhancing the Quality Management System. This role offers growth opportunities for an adept regulatory professional to oversee emerging markets and col...

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...

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...

Lead the charge in developing CMC regulatory strategies, ensuring compliance and aligning with commercial objectives while managing cross-functional teams to drive project success in the pharmaceutica...

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...

Advance regulatory strategy and submissions for CMC in pharmaceuticals, collaborating with cross-functional teams to ensure compliance with FDA, EMA, and ICH standards while overseeing product lifecyc...

Champion the development of regulatory data strategies and governance frameworks, ensuring data accuracy and compliance. Lead transformative initiatives that enhance regulatory information management...

Drive global regulatory compliance for fragrance ingredients, navigating complex laws while advising cross-functional teams. Exercise independent judgment and shape strategies for proactive risk manag...

Empower quality excellence by managing CAPA processes, supporting cross-functional teams, and ensuring compliance within regulatory frameworks for impactful corrective actions and continuous quality i...

Empower the Regulatory Affairs team by driving compliance and strategy across global projects. Lead regulatory submissions, monitor changes, and collaborate with stakeholders to ensure successful prod...

Execute non-compartmental and compartmental PK/PD analyses to support nonclinical and clinical studies, ensuring compliance with GxP/GLP standards. Collaborate with CROs and prepare datasets for regul...

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...