Senior Regulatory Affairs Specialist Jobs in Rahway, NJ

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...

Drive global regulatory strategy execution, ensuring compliance and market access while fostering collaboration across business units and regions, streamlining processes in the medical device industry...

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...

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...

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...

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...

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...

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...

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...

Unlock quality excellence in global clinical trials by leading risk-based management strategies. Collaborate across teams to ensure compliance and enhance processes, making a meaningful impact in pati...

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...