Senior Regulatory Affairs Specialist Jobs in Houston, TX

Oversee GxP quality assurance activities for drug substance and product, ensuring compliance across development and commercial programs. Collaborate with cross-functional teams in a fast-paced environ...

Champion recall operations by managing teams, executing FDA-compliant strategies, and driving cross-functional alignment to ensure timely product corrections and removals while maintaining regulatory...

Empower clinical development by leading strategic initiatives across the lifecycle of innovative therapies. Drive decision-making with data analysis, oversee early-phase studies, and collaborate cross...

Empower the sales team by coordinating pre-sale trials, ensuring efficient execution, enhancing customer engagement, and analyzing data to drive improvements for better outcomes and satisfaction throu...

Deliver excellence in Quality Assurance Engineering by ensuring precision and reliability in products. Develop and maintain evaluation systems, implement inspection methods, and manage product quality...

Lead key Medical & Scientific Affairs projects, ensuring timely delivery and operational success by utilizing advanced project management methodologies and collaborative teamwork to enhance medical in...

Join a team that's defining the future of proposal management, leading high-stakes submissions with expertise and collaboration. Drive innovation, mentor teams, and ensure compliance to secure strateg...

Lead the charge in managing FSP teams to ensure compliance, quality, and efficiency in clinical trials. Mentor staff, oversee supplier performance, and drive communication across stakeholders while mo...

Architect robust validation processes to ensure system compliance and integrity while mentoring a team. Drive quality through risk assessments and validation documentation in a regulated pharmaceutica...

Pioneer the development of project controls execution plans while collaborating closely with project teams to ensure effective planning, scheduling, and cost management strategies that drive project s...

Drive product management and commercialization for innovative immunoassays, ensuring market success and aligning strategies with customer needs, while mentoring junior team members and guiding cross-f...

Accelerate progress at the forefront of engineering by integrating electrical and mechanical systems. Contribute to R&D initiatives for submarine weapon systems while mentoring technicians in dynamic...

Join us to elevate quality standards in radiopharmaceutical development. Lead GMP compliance and quality systems while mentoring junior staff. Drive improvement across our portfolio, ensuring regulato...

Lead the charge in Quality Control for late-stage cell therapy programs, ensuring seamless technology transfers, regulatory compliance, and project execution through collaboration with cross-functiona...

Lead clinical QA initiatives to ensure compliance with regulations, promote operational excellence, and drive continuous improvement across the organization, collaborating with internal teams and exte...

Join a team that's dedicated to ensuring software quality by developing and executing comprehensive tests. Collaborate with peers to enhance testing methodologies and mentor teammates in a dynamic and...

Engage with key stakeholders to develop and lead strategic policy initiatives that drive Travere Therapeutics' mission in rare disease advocacy and legislation. Collaborate cross-functionally to influ...

Pioneer process advancements in sputtering and thin-film deposition, enhancing manufacturing yield, capability, performance, and product commercialization in a cutting-edge engineering environment...

Reimagine clinical contract negotiations by joining a dynamic team committed to efficiency and compliance. Support various contract types and ensure streamlined processes while interfacing with stakeh...

Drive enterprise-wide operational excellence initiatives by leading continuous improvement efforts, deploying methodologies like Lean and Six Sigma, and fostering cross-functional collaboration to enh...

Serve as a key member of the engineering team, leading mechanical design efforts throughout the product lifecycle, from concept to field operations, ensuring compliance and efficiency in high-pressure...

Join a dynamic team as a Senior Research Scientist, where you will lead innovative projects in evidence synthesis. Collaborate with experts while managing deliverables and mentoring junior researchers...

Lead the charge in ensuring quality compliance by conducting thorough GMP and GDP audits across Gilead’s global manufacturing and supply network, enhancing internal policies and external partnerships...

Engage in the development and quality control of clinical documents, ensuring compliance with regulatory standards while managing projects and fostering team collaboration for successful submissions...

Champion process improvement initiatives in fabrication or assembly, enhancing productivity and quality. Collaborate with manufacturing teams to identify issues and lead projects, ensuring effective e...