Director, Regulatory Affairs Jobs in Lexington, MA

Lead the strategic development and execution of pricing and market access initiatives for a portfolio focused on rare diseases, collaborating across teams to optimize product access and market perform...

Lead regulatory strategy development and execution for US and Canada markets, ensuring compliance and alignment with global requirements. Interface with authorities and support product commercializati...

Transform quality compliance through strategic leadership and oversight. Own global quality compliance programs, ensuring regulatory alignment and fostering a proactive risk-based culture that support...

Bring your expertise to a dynamic team as you lead high-impact medical content development. Collaborate cross-functionally, mentor talent, and strategize with clients to enhance medical education and...

Champion quality in clinical development by providing strategic oversight for GCP activities. Collaborate across teams to ensure compliance and continuous improvement, while maintaining readiness for...

Join us in driving regulatory strategies and supporting successful product commercialization in North America. Utilize your expertise to lead cross-functional initiatives and ensure compliance with ev...

Champion global access programs for innovative cancer therapies, ensuring alignment with clinical, regulatory, and patient needs. Lead cross-functional teams to enhance early access strategy and opera...

Join a team that's shaping global compliance through innovative strategies. This leadership role involves driving regulatory initiatives, advising on compliance risks, and influencing key business pri...

Unlock brand growth through dynamic marketing strategies and leadership, driving cohesive communications and collaborations across teams in the gastroenterology space while managing a high-performing...

Oversee and enhance sterility assurance by designing and implementing Contamination Control Strategies aligned with regulatory standards. Collaborate closely with cross-functional teams to drive conti...

Drive global CMC regulatory strategies and submissions for clinical and commercial products. Collaborate cross-functionally to ensure compliance, lifecycle management, and timely delivery of high-qual...

Transform your career by leading digital quality compliance initiatives, driving improvements across GxP systems, and enhancing operational excellence through innovative solutions in a collaborative e...

Shape the future of healthcare compliance by leading strategic initiatives, managing regulatory risks, and fostering an ethical culture. Collaborate with leadership to ensure adherence to state and fe...

Champion regulatory strategies and submissions for global medical products, ensuring compliance across major markets while leading cross-functional teams and driving process improvements in a collabor...

The Director of Quality at Catalent, Inc. will lead the Boston Quality Department, overseeing Quality Assurance and Laboratory functions. This role involves ensuring compliance with regulatory standar...

Lead the implementation and oversight of Data Integrity compliance in Quality Control, managing regulatory alignment, training efforts, and data validation while enhancing processes for excellence in...

Advance quality standards by leading Supplier Quality initiatives across networks, ensuring compliance with global quality management systems and fostering supplier development through strategic colla...

Join a dynamic team as a strategic leader in global regulatory project management, driving complex submissions and fostering cross-regional collaboration to enhance market access and ensure compliance...

Lead the charge in Medical Affairs, driving strategy, team development, and external engagements. Oversee compliance and scientific rigor while fostering partnerships with KOLs and managing budget and...

Join an innovative team conducting vital research to enhance food safety. Contribute to developing analytical methods for detecting lead in food contact materials while collaborating with cross-functi...

Empower quality assurance excellence by overseeing GMP operations and supporting compliance in clinical environments. Lead inspection readiness and continuous improvement initiatives while fostering c...

Innovate regulatory strategies for multifaceted projects, ensuring seamless integration across global development, while providing expert leadership in pharmaceutical innovation and compliance...

Join a team that's transforming quality systems in the biotech space. Drive compliance and vendor oversight, ensuring GxP system effectiveness while fostering strategic partnerships across departments...

Drive product quality and customer confidence by leading a team in quality investigations and continuous improvement initiatives, while fostering collaboration and accountability across functions to a...

Create impactful strategies by leading R&D assessments and initiatives, collaborating with senior leadership to drive value and innovation, and fostering an inclusive culture within cross-functional t...