Senior Regulatory Affairs Specialist Jobs in Rockville, MD

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...

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...

Lead global strategy for Notified Body engagement, ensuring compliance, managing audits, and driving certification readiness across various jurisdictions. Guide integration assessments, enhance proces...

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...

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...

Elevate the regulatory landscape by guiding strategic promotional communications for Oncology products. Shape impactful messaging while ensuring compliance and aligning with evolving regulations and F...

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...

Unlock your potential by overseeing site management and monitoring for clinical trials, ensuring compliance with regulations and enhancing site relationships to drive quality and timely delivery of cl...

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...

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...

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

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...

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...

Join a team that's dedicated to advancing chemical safety by managing complex regulatory projects and providing expert guidance on environmental policies like TSCA. Collaborate with clients and regula...

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...