Senior Regulatory Affairs Specialist Jobs in Baltimore, MD

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

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...

Lead the charge in developing global regulatory strategies for clinical programs. Manage regulatory operations for product lifecycle while collaborating with cross-functional teams to ensure successfu...

Collaborate with cross-functional teams to oversee regulatory activities for a portfolio of Pharmaceutical Diagnostics products, ensuring compliance and strategic alignment with global standards throu...

Lead regulatory compliance programs ensuring inspection readiness and proactive risk management across cross-functional teams. Monitor compliance health, manage data quality, and drive improvements al...

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

Join a team that's advancing regulatory strategies for drug substance manufacturing. Lead the charge in selecting and justifying Regulatory Starting Materials, ensuring compliance with global guidelin...

Unlock potential by driving regulatory submissions and managing documentation. Collaborate with global teams to align on strategies, ensuring compliance and effective communication while fostering a c...

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...

Lead the charge in FTZ operations, ensuring compliance and accurate material movement in cell therapy logistics. Collaborate across teams to maintain inventory control, regulatory adherence, and suppo...

Collaborate to enhance the ethical oversight of human subjects research. Engage in compliance oversight, analyzing incident reports, and supporting IRB interactions. Utilize in-depth regulatory knowle...

Unlock your potential as a strategic leader in global regulatory affairs, driving innovative cardiovascular solutions and ensuring rapid approval processes while managing complex development programs...

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...

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...

Shape the future of transit by overseeing specification development, ensuring compliance with standards, and collaborating across departments to drive efficient project delivery. Be part of a transfor...

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...

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...

Lead engineering initiatives to enhance equipment reliability and efficiency in biopharma manufacturing. Collaborate cross-functionally to optimize processes and ensure compliance while mentoring team...

Empower excellence by conducting systematic QA audits to ensure compliance with GLP and regulatory standards, while mentoring team members and driving process improvements across diverse study discipl...

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...