Senior Regulatory Affairs Specialist Jobs in Irving, TX

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

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

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...

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...

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...

Empower quality advancements by leading manufacturing investigations and driving continuous improvement. Collaborate cross-functionally to enhance process validation and ensure compliance, while deliv...

Contribute to regulatory excellence by coordinating U.S. submissions, ensuring compliance with FDA standards, and maintaining vital documentation for the Obesity Therapeutic Area, while collaborating...

Lead end-to-end GCP audits globally, ensuring compliance and driving improvements in clinical studies. Collaborate with stakeholders to interpret regulations and support regulatory inspections in a dy...

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...

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...

Champion the validation of cutting-edge lab instrumentation while collaborating with diverse teams to ensure customer readiness and operational excellence. Your expertise will drive quality and compli...

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...

Transform regulatory writing by leading complex submissions, mentoring teams, and ensuring compliance. Drive innovation and improve processes while collaborating across teams to enhance product succes...

Drive impactful medical communication strategies by crafting precise scientific content and collaborating with cross-functional teams to meet diverse client needs within a dynamic healthcare landscape...

Join a strategic leadership role that executes regulatory strategies globally, overseeing complex submissions and driving cross-functional collaboration to ensure successful market access and complian...

Champion quality assurance and compliance in R&D for surgical ophthalmic devices, driving innovation and ensuring regulatory standards while managing projects and resources independently to enhance pr...

Shape the future of clinical support by driving revenue through strategic partnerships and educational programs. Foster relationships with healthcare professionals and provide essential training while...

Unlock potential by driving market growth and providing advanced clinical support. Engage with sales teams and healthcare professionals to enhance service delivery and product adoption while managing...

Empower innovation in quality compliance by overseeing GCP activities, conducting audits, managing regulatory inspections, and ensuring effective risk mitigation strategies throughout clinical develop...

Champion the administration and optimization of laboratory systems, ensuring seamless deployment, validation, and integration of informatics solutions within a GMP environment to enhance data integrit...

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...

Join a team that's dedicated to maintaining Good Clinical Practice and human subject protection. Oversee site monitoring, ensure compliance, and support clinical studies through effective communicatio...

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...

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...

Join a team that's driving patient access to groundbreaking gene therapy products. Leverage your expertise in health systems and reimbursement to educate stakeholders and facilitate timely product ava...