Director, Regulatory Affairs Jobs in Durham, NC

Accelerate progress at the forefront of pharmaceutical development by leading regulatory strategies. Collaborate cross-functionally to ensure timely submissions and compliance with FDA standards, driv...

Innovate and execute regulatory CMC strategies for radiopharmaceutical products, ensuring compliance across global markets. Collaborate with cross-functional teams to support submissions and enhance p...

Drive global regulatory strategy for medical imaging products, ensuring compliance across the software development lifecycle. Lead a dynamic team, engaging with cross-functional partners and regulator...

Join a team that's shaping regulatory strategies in biopharmaceuticals. This role involves leading regulatory submissions and collaborating across project teams to ensure compliance while advancing co...

Drive global regulatory excellence by leading teams in strategic operations, UDI, and compliance. Partner cross-functionally to ensure market access and develop robust governance frameworks, while fos...

Manage the governance of the enterprise-wide specimen collection kit program. Oversee quality assurance initiatives, ensure regulatory compliance, and implement a robust Quality Management System to e...

Partner with us to lead global regulatory affairs for innovative pharmaceutical products. Oversee strategy, team development, and agency negotiations while ensuring compliance and operational excellen...

Accelerate progress at the forefront of global regulatory affairs by leading strategies for IND/CTA approvals, ensuring product launches, and executing post-marketing initiatives in the oncology secto...

Pioneer regulatory excellence by leading FDA submissions and compliance. Manage the lifecycle of medical product filings, ensuring alignment with evolving regulations across diverse jurisdictions in a...

Join a high-impact team as you shape global regulatory strategies, lead submissions, and ensure compliance across complex portfolios. Drive innovative success from development through post-approval wh...

Shape the future of regulatory affairs by driving strategies for late-stage development programs. Collaborate across teams to ensure compliance, manage submissions, and support critical milestones in...

Engage as a Global Regulatory Leader, driving innovative regulatory strategies and interactions to streamline product development and global approval processes, while ensuring compliance and effective...

Champion global regulatory activities, ensuring high-quality submissions and strategic partnerships. Support lifecycle management across late-stage development, driving compliance with U.S. and intern...

Reimagine Regulatory Affairs by leading complex outsourcing programs and driving client success. Utilize deep expertise in strategy and operations to manage projects, mentor teams, and deliver tailore...

Shape the future of regulatory affairs by driving product development and global registration strategies, collaborating with diverse teams to ensure compliance and efficiency throughout the product li...

Elevate your career as you ensure regulatory compliance in product development and manufacturing. Collaborate with project teams and guide submissions to domestic and international agencies while main...

Transform legislative objectives by leading multistate efforts, drafting vital legislation, and engaging with external lobbyists for impactful policy development and advocacy...

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...

Shape the global Advertising & Promotional Compliance strategy, leading regulatory efforts and ensuring compliance for promotional materials while collaborating with cross-functional teams to enhance...

Lead the global GxP audit strategy and ensure quality compliance across R&D. Drive audit initiatives, manage risks, and cultivate a high-performing team to enhance quality culture and inspection readi...

Join a dynamic team and lead regulatory strategies for in vitro diagnostics, ensuring compliance and successful submissions while collaborating cross-functionally. Manage project timelines and mentor...

Shape the future of quality excellence by leading enterprise risk management initiatives. Drive standards, embed risk principles, and cultivate a risk-aware culture across the organization to ensure c...

Join a team that's enhancing clinical trial solutions by building strong relationships with key stakeholders and leveraging your sales expertise to expand IRB and IBC services in the life sciences ind...

Lead the regulatory CMC strategy ensuring compliance for complex manufacturing processes in biologics. Engage with internal teams and regulatory authorities to drive successful submissions and mitigat...

Transform the regulatory landscape by shaping product communications and ensuring compliance with FDA regulations. Guide promotional reviews, mentor team members, and navigate evolving regulatory chal...