Regulatory Affairs Specialist Jobs in New York, NY

Join a team that's dedicated to compliance excellence by managing the product complaint process and facilitating investigations. Collaborate with internal stakeholders to drive improvements and uphold...

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...

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...

Join a team that's dedicated to advancing regulatory strategies for innovative SaMD products. Collaborate cross-functionally to drive compliance, manage documentation, and ensure readiness for audits...

Unlock potential by leading regulatory CMC strategies for oncology products, coordinating submissions, and collaborating across teams to ensure compliance and successful product registration in a dyna...

Drive regulatory strategy and initiatives for assigned products in the US and Canada. Collaborate with internal teams and Health Authorities to ensure compliance, support submissions, and navigate com...

Optimize global regulatory submissions and strategies to advance novel therapeutics in Oncology. Collaborate with teams and regulatory agencies to drive compliance and enhance drug development process...

Elevate regulatory excellence by managing global submissions and interactions. Collaborate across teams to ensure compliance and drive the development of innovative therapies. Play a pivotal role in n...

Unlock your potential by driving regulatory strategy in oncology, ensuring compliance through global submissions and collaboration within cross-functional teams. Contribute to the development of innov...

Oversee regulatory review of promotional materials for pharmaceutical products. Ensure compliance with FDA regulations while collaborating cross-functionally to support effective advertising strategie...

Transform regulatory strategies for the allergy portfolio, guiding product launches, compliance, and cross-functional collaboration, while mentoring talent and enhancing impact on health and sustainab...

Transform regulatory strategies by supporting global submissions in oncology, coordinating agency meetings, and collaborating across teams to ensure compliance and drive clinical development goals. Ma...

Drive the advancement of global regulatory submissions in oncology, ensuring compliance for innovative therapeutics through collaborative interactions and strategic planning in a dynamic, science-focu...

Champion regulatory excellence in a dynamic environment, driving compliance and oversight through effective leadership. Foster relationships, manage audits, and guide the team in enhancing organizatio...

Transform safety and quality compliance by leading initiatives that ensure GMP adherence and operational excellence in clinical supply manufacturing, working closely with cross-functional teams to dri...

Manage the preparation and review of regulatory labeling submissions, ensuring compliance with FDA standards while coordinating artwork and drug listings for commercial products and maintaining docume...

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...

Shape the future of Regulatory CMC with innovative AI solutions, enhancing workflows through digital transformation. Collaborate across teams for greater productivity and operational excellence in a f...

Serve as a strategic regulatory leader, guiding nonclinical drug development and ensuring compliance for successful clinical entry and regulatory submissions, collaborating with cross-functional teams...

Engage in global regulatory compliance efforts while enhancing our Quality Management System. This role offers a chance to lead regulatory strategies, influence cross-functional teams, and contribute...

Drive regulatory compliance and quality management for global market access while enhancing your expertise in medical device regulations and expanding your leadership role in this dynamic, cross-funct...

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...

Transform regulatory affairs by leading initiatives that drive innovation and empower cross-functional teams. Shape product strategies, oversee submissions, and collaborate with the FDA to enhance acc...

Champion regulatory excellence by leading postmarket strategies for product compliance, driving collaboration across teams to ensure timely submissions and navigate complex regulatory landscapes for c...

Transform compliance through expertise in HR regulations, policy management, and training. Support a culture of accountability while navigating multi-state employment laws across diverse teams, ensuri...