Senior Regulatory Affairs Specialist Jobs in Boston, MA

Lead the charge in AD&QC activities for late-stage oligonucleotide programs, ensuring regulatory submissions, compliance, and collaboration across teams to drive successful manufacturing and product q...

Unlock potential by leading a high-performing CRA team, ensuring compliance with ICH-GCP and local regulations while enhancing site relationships and driving clinical trial excellence. Spearhead resou...

Take ownership of a comprehensive compliance program, ensuring regulatory readiness and effective oversight across multiple states in telehealth. Lead a team dedicated to establishing policies and fos...

Collaborate with cross-functional teams to drive success in analytical CMC activities, ensuring timely execution and management of development projects while maintaining dynamic relationships with ext...

Lead the management of clinical biosamples across trials, ensuring compliance and integrity. Collaborate with stakeholders to oversee the lifecycle, shipment, and documentation of biosamples, supporti...

Lead analytical development and quality control for biologics, ensuring best practices and compliance in preclinical and clinical programs. Collaborate with cross-functional teams and external partner...

Collaborate with cross-functional teams to ensure promotional compliance and adherence to FDA regulations. As a key regulatory expert, mentor staff and lead strategic oversight of products within a dy...

Champion regulatory excellence as a Senior Manager guiding US Ad/Promo compliance. Leverage your expertise in FDA regulations to ensure promotional materials meet standards, collaborating cross-functi...

Optimize siRNA design and off-target assessment by integrating genomic data and machine learning. Collaborate with cross-functional teams to advance RNA-based therapeutics, ensuring safer and more sel...

Lead the charge in enhancing data products for drug discovery and pre-clinical research. Collaborate with cross-functional teams to bridge scientific needs and data-driven solutions, driving impactful...

Inspire innovation by leading the design of complex medical devices, translating user needs into requirements, and collaborating across teams to ensure integration and compliance for optimal product p...

Lead patient safety initiatives across global programs, driving collaboration, regulatory compliance, and quality in pharmacovigilance operations. Engage with clients, streamline project performance...

Support our team as a key pharmacovigilance expert driving innovative PV systems and AI strategies. Collaborate cross-functionally to ensure compliance, enhance safety data processes, and lead moderni...

Analyze and lead major projects in biopharma manufacturing, ensuring processes are compliant, efficient, and continuously enhanced. Collaborate with cross-functional teams to drive technical solutions...

Champion the advancement of biocompatibility evaluations for medical devices. Lead assessments, develop SOPs, and collaborate across teams to ensure compliance with regulatory standards and enhance pr...

Transform government pricing strategies by managing client relations and ensuring accurate federal drug price calculations while mentoring a team of analysts and providing expert guidance in complianc...

Join a team that's redefining clinical development through advanced biostatistics. Leverage your expertise in statistical analysis and support Phase I-IV trials, collaborating with global pharmaceutic...

Join a team that's committed to driving quality excellence in R&D. As a leader, you'll ensure compliance, manage audits, support inspections, and foster a culture of continuous improvement across clin...

Advance your career by ensuring quality and compliance in aerospace design. Collaborate closely with teams to review engineering models and documents, acting as a key quality gate for deliverables tha...

Lead quality engineering initiatives and teams, ensuring compliance and operational excellence. Balance technical oversight with resource management, driving quality in manufacturing, validation, and...

Champion quality in design by ensuring compliance with regulatory standards and customer expectations. Collaborate across teams to integrate quality into products, drive risk management, and enhance m...

Unlock potential by leading quality assurance initiatives across medical product development, ensuring compliance with regulations and standards, and collaborating with cross-functional teams to enhan...

Champion analytical advancement by overseeing development strategies for drug substances and products. Provide leadership in compliance and lifecycle management while collaborating with teams to ensur...

Join a team that leads scientific strategy for clinical studies, collaborating across functions to ensure patient safety and study integrity while driving high-quality data review practices throughout...

Unlock potential by serving as a Liquid Chromatography expert, leading method development and analytical strategy for synthetic drug products. Collaborate cross-functionally to drive innovative drug d...