Director, Regulatory Affairs Jobs in Gaithersburg, MD

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...

Join a pivotal role in regulatory affairs, guiding promotional materials in compliance with FDA and provincial guidelines in a dynamic, remote environment. Lead the Materials Review Committee and shap...

Innovate the future of regulatory labeling by driving strategies across global teams, ensuring compliance and quality at all stages of product development while collaborating with key stakeholders to...

Accelerate regulatory strategy development for oncology products, leading global initiatives to secure IND/CTA approvals and marketing applications. Collaborate with cross-functional teams to navigate...

Transform regulatory affairs in oncology by leading strategic submission initiatives and cross-functional collaborations, ensuring compliance and quality for impactful development programs. Drive regu...

Drive global regulatory strategies for diagnostics and devices, ensuring compliance and influencing policy while collaborating with senior leadership to support business-critical decisions across mark...

Lead the charge in transforming global regulatory strategies into successful outcomes. Oversee regulatory activities and empower teams to ensure quality compliance, timely delivery, and robust cross-f...

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...

Advance regulatory strategies and oversight for global clinical trials. Support submission preparation, manage CRO interactions, and collaborate cross-functionally to navigate regulatory challenges an...

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Join a team that shapes global regulatory strategy in a fast-paced environment. You will lead comprehensive regulatory plans, ensuring alignment and execution from development to post-marketing, impac...

Pioneer actionable insights in regulatory affairs, driving portfolio strategies for innovative therapies in respiratory and immunology. Collaborate cross-functionally to translate regulatory intellige...

Join a team that drives global regulatory strategy for innovative products. You will lead regulatory affairs for clinical development, ensuring alignment with health authority requirements and facilit...

Lead global regulatory strategies for oncology programs, ensuring compliance and effectively interacting with regulatory agencies for product approvals in late-stage development...

Lead regulatory support for Neurology and Oncology agents, driving strategies and submissions for global approvals. Collaborate across teams to enhance development timelines and ensure compliance with...

Elevate regulatory strategies for drug development, leading a diverse team to ensure compliance with global standards and drive successful product lifecycles across key markets...

Lead the charge in regulatory strategies for oncology products, overseeing submission processes and health authority negotiations to achieve rapid, competitive approvals while mentoring cross-function...

Shape the future of regulatory policy and advocacy to enhance patient care through strategic insights, collaboration, and leadership across U.S. regulatory frameworks, ensuring proactive alignment wit...

Drive regulatory excellence by managing submissions, guiding teams, and ensuring compliance. Utilize your expertise to support global projects and foster collaboration in a fast-paced environment focu...

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...

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...

Drive quality assurance in GMP operations, ensuring compliance and product integrity while collaborating with internal and external stakeholders. Contribute to clinical manufacturing excellence throug...

Innovate and lead the global regulatory strategy for complex products, ensuring rapid approvals and advantageous labeling while managing cross-functional teams and stakeholder interactions to enhance...

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...

Join a dynamic team to lead regulatory strategies, ensuring compliant promotional practices in pharma. Collaborate cross-functionally to guide materials review processes and implement innovative tacti...