Director, Regulatory Affairs Jobs in Gaithersburg, MD

Unlock potential by shaping global regulatory strategies that enable successful product launches. Collaborate across functions to ensure compliance and lead innovative submission processes throughout...

Join a team that's committed to driving innovative regulatory projects, ensuring compliance, and collaborating with cross-functional teams to secure timely submissions and approvals for products in th...

Oversee regulatory compliance operations, ensuring adherence to laws and regulations for assigned products/services while collaborating across departments to implement effective compliance strategies...

Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...

Transform regulatory strategy and operations across CMC and clinical activities, leading a high-performing team to ensure compliance and successful product approvals from development through post-appr...

Lead the advancement of regulatory data strategy, governance, and digital ecosystems. Collaborate with cross-functional teams to enhance regulatory processes and data quality while executing innovativ...

Shape the future of patient access by leveraging regulatory strategy expertise to guide pharmaceutical clients in navigating complex regulatory landscapes and developing innovative access solutions fo...

Unlock innovative regulatory solutions as you lead global strategies to expedite product approvals, ensure compliance, and support cross-functional teams in navigating local and international regulato...

Join a dynamic team as you drive regulatory strategies and ensure compliance in post-approval activities for CMC processes. Collaborate cross-functionally, influencing clinical outcomes and advancing...

Manage global regulatory strategies for clinical and commercial product registrations. Ensure compliance and successful market access for the PSMA franchise. Lead cross-functional collaborations and d...

Lead the development and execution of global CMC regulatory strategies, ensuring compliance from discovery through commercialization. Collaborate with cross-functional teams to address regulatory requ...

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

Shape regulatory strategies for infectious disease products, leading cross-functional teams and global interactions from early development through registration, ensuring compliance and successful prog...

Join a global team to shape regulatory strategies in biotechnology, supporting product development and lifecycle management in Inflammation and Rare Diseases. Lead regulatory efforts, ensure complianc...

Take ownership of regulatory affairs operations, leading teams to enhance processes within clinical trials while ensuring compliance with regulations and fostering collaboration across departments...

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...

Unlock potential by leading regulatory strategy for clinical gene therapy programs. This execution-focused role drives submissions and health authority interactions while collaborating across cross-fu...

Drive your career forward by leading regulatory labeling and compliance strategies in a dynamic role that collaborates across teams to ensure successful product lifecycle management and adherence to i...

Drive strategic federal policy advocacy to enhance public initiatives and patient access by engaging effectively with lawmakers and regulators. Partner with stakeholders to shape impactful policy outc...

Join a team that's shaping the future of global regulatory strategy. Your expertise will drive compliance, oversee submissions, and lead a dynamic regulatory team in executing key strategies for produ...

Unlock potential by guiding global regulatory strategies for innovative AI/ML healthcare solutions. Collaborate cross-functionally to navigate complex regulations while balancing innovation and patien...

Lead global regulatory strategy for transformative cell therapies, guiding complex programs through critical milestones with a focus on patient needs and competitive positioning to facilitate timely a...

Lead the global GMP/GDP audit organization, enhancing predictive compliance intelligence while mitigating risks through advanced analytics and effective audit strategies...

Transform the regulatory landscape by leading labeling efforts for animal health products, ensuring compliance and excellence throughout the product lifecycle while collaborating with cross-functional...

Drive your career by leading a global trade compliance program, ensuring adherence to international regulations while enhancing governance and operational efficiency across a complex business landscap...