Senior Regulatory Affairs Specialist Jobs in Gaithersburg, MD

Transform regulatory strategies in FDA Pharma and IVDR, ensuring compliance and driving product approvals. Collaborate with cross-functional teams, mentor associates, and enhance processes to support...

Advance your career by leading clinical research projects and ensuring compliance with timelines and standards. Collaborate with stakeholders and clinical sites to safeguard subjects' rights and data...

Drive your career forward by leading regulatory labeling and compliance strategies in a dynamic role that collaborates across teams to ensure successful product lifecycle management and adherence to i...

Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...

Advance your career by leading regulatory writing initiatives for vital U.S. tobacco submissions. Collaborate with global teams to ensure regulatory compliance and clear communication, driving key pro...

Lead the development and execution of global CMC regulatory strategies, ensuring compliance from discovery through commercialization. Collaborate with cross-functional teams to address regulatory requ...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Shape the future of cell therapy by leading global regulatory strategies for high-impact programs, driving competitive pathways to approval and access for patients, while mentoring teams and engaging...

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

Drive regulatory advocacy efforts to shape and influence utility commission cases, engaging with stakeholders and crafting strategic positions that maximize value and promote fair practices in the ene...

Champion regulatory advocacy efforts by managing contested cases and building external coalitions. Collaborate with cross-functional teams to craft and coordinate impactful regulatory materials that d...

Engage with government and regulatory bodies to shape automotive safety and technology policies. Lead communications, manage submissions, and foster collaboration across teams to ensure compliance and...

Lead the charge in steering promotional regulatory strategy to ensure compliance and foster trust among healthcare professionals. Drive team performance and provide strategic guidance on FDA regulatio...

Lead the charge in global post-market surveillance by overseeing deliverables, providing team leadership, and ensuring regulatory compliance for medical devices. Engage in strategy, analysis, and cros...

Join a dedicated team driving global regulatory strategy for early-stage oncology products. You'll execute and manage high-quality submissions and collaborate across functions to ensure compliance and...

Lead the charge in ensuring continuous regulatory compliance and inspection readiness for R&D technology solutions by executing audit readiness strategies, embedding GxP compliance, and collaborating...

Shape client success by leading complex consulting projects, integrating diverse workstreams into actionable insights, and driving high-quality deliverables while fostering team growth and managing st...

Unlock potential by developing impactful policy content that shapes public health initiatives and drives scientific rigor. Collaborate across diverse teams to enhance access to quality medicines while...

Join a team that drives regulatory excellence for clinical development, ensuring strategic and compliant submissions. Collaborate cross-functionally to accelerate drug approval processes while oversee...

Shape the future of patient access by leveraging regulatory strategy expertise to guide pharmaceutical clients in navigating complex regulatory landscapes and developing innovative access solutions fo...

Join us to lead utility rebate and incentive efforts for geothermal heating. Collaborate with our Policy team to shape regulatory strategies and build relationships with key stakeholders across multip...

Pioneer high-impact technical solutions in supply chain and manufacturing. Lead complex assessments and development projects, guiding cross-functional teams to deliver key outcomes for global access t...

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

Empower project delivery by leading BIM execution across multi-discipline teams. Drive model coordination, quality assurance, and collaboration efforts to ensure project standards and client requireme...

Accelerate clinical trial success by optimizing monitoring strategies and processes for efficient, quality data management in alignment with regulatory standards and timelines...