Explore senior regulatory affairs specialist jobs with organizations seeking experienced professionals to guide products through complex regulatory requirements. These roles combine subject-matter expertise, strategic judgment, and cross-functional leadership to support compliant product development and market access. Ladders features vetted professional opportunities paying $100,000 or more.
Senior regulatory affairs specialists interpret regulations and guidance, assess how requirements affect products and business plans, and coordinate regulatory activities across the product lifecycle. Depending on the industry, they may prepare and review submissions, maintain regulatory documentation, support audits and inspections, and communicate with regulatory agencies. They also help teams identify risks early and keep programs aligned with applicable standards.
Responsibilities vary by employer and sector, but often include developing regulatory strategies, managing submission timelines, reviewing technical and labeling materials, tracking regulatory changes, and advising partners in quality, clinical, research, manufacturing, and commercial teams. Employers may look for strong writing and project-management skills, careful attention to detail, sound judgment, and experience with relevant regulations and submission processes.
Senior regulatory affairs specialists work across fields such as pharmaceuticals, biotechnology, medical devices, diagnostics, and other regulated industries. Their experience can lead to opportunities in regulatory strategy, program leadership, regulatory operations, quality, or people management. Scope and job requirements depend on the organization, product type, and markets served.
Browse senior regulatory affairs specialist opportunities on Ladders to discover vetted roles paying $100,000 or more. Compare responsibilities, qualifications, and work arrangements, then focus your search on positions that match your regulatory expertise and career goals.
$107K - $195K *
Engineer innovative hardware solutions by designing, developing, and testing complex electronic systems. Collaborate with teams through all product life cycle phases, ensuring quality and performance...
Reposted 2 days ago
$120K - $181K *
Transform regulatory strategies for global product approvals, ensuring compliance and collaboration across teams. Lead a high-performing Regulatory Affairs team to achieve business goals in Lung Healt...
2 weeks ago
Senior Operations Quality Engineer
$95K - $181K *
Join a team that's dedicated to ensuring product quality and compliance. As a Senior Operations Quality Engineer, you'll drive continuous improvement initiatives and collaborate with cross-functional...
Reposted 3 days ago
$125K - $165K *
Unlock potential by leading project lifecycles and client relationships. Manage teams, coach engineers, and ensure quality in validation projects while delivering hands-on technical expertise and fost...
1 week ago
FSP-Senior Bioanalytical Study Manager
$110K - $130K *
Unlock potential by leading a diverse portfolio of projects, ensuring client satisfaction and operational excellence. Drive efficiency, manage resources, and serve as the primary liaison between clien...
1 week ago
Internal Clinical Research Associate
$87K - $145K *
Drive clinical trial success by supporting study operations, ensuring compliance, and managing documentation from start to finish. Collaborate with cross-functional teams to maintain quality standards...
2 days ago
$90K - $107K *
Elevate your career by providing essential quality support to manufacturing, ensuring compliance with regulatory and safety standards while promoting continuous improvement and collaboration across te...
Reposted 1 week ago
Associate Manager, Quality Assurance
$118K - $196K *
Champion quality excellence by leading a dynamic Quality Engineering team, ensuring compliance with standards and fostering a culture of continuous improvement while driving team engagement and perfor...
2 weeks ago
Sr Principal Contract Administrator
$112K - $168K *
Join a team that's pivotal in managing complex contracts and negotiations, ensuring compliance and strategic alignment. Collaborate across functions to drive successful proposal execution and contract...
2 days ago
$92K - $102K *
Lead the charge in quality assurance within a groundbreaking team, innovating processes and systems that deliver cutting-edge cell therapy solutions, ensuring compliance and excellence throughout ever...
4 weeks ago
Senior Engineer/Manager, Device Development - Combination Products
$146K - $161K *
Join us to lead device development for innovative combination products, driving technical excellence and project management. Collaborate with cross-functional teams and external partners to ensure suc...
3 weeks ago
Senior Global Marketing Manager (Antibody)
$129K - $193K *
Transform the future of transplant diagnostics by driving market growth and adoption of innovative molecular diagnostics. Collaborate cross-functionally to create compelling strategies and campaigns t...
1 week ago
$100K - $120K *
Join a team that's redefining procurement strategies in the paper and packaging sector. Lead supplier management and strategic sourcing initiatives to drive cost savings and ensure supply continuity a...
2 weeks ago
$100K - $120K *
Join a team that's driving strategic sourcing and supplier management for paper and packaging. This role focuses on category strategy, supplier performance, and cost savings, ensuring supply continuit...
2 weeks ago
Senior Clinical Research Associate
$88K - $105K *
Oversee the clinical study lifecycle at multiple sites, ensuring compliance with protocols and regulatory standards. Collaborate with cross-functional teams to achieve project milestones effectively w...
Reposted yesterday
Senior Product Engineer, RCM Operations
$160K - $185K *
Lead the charge in enhancing billing operations by designing reliable integrations, automating claims processes, and delivering user-friendly customer-facing products to optimize revenue cycle managem...
Reposted 4 weeks ago
Senior Clinical Research Associate
$95K - $115K *
Engage with diverse teams to oversee clinical study sites, ensuring compliance and efficient study conduct through proactive problem-solving and collaboration with site personnel and internal stakehol...
Reposted yesterday
Senior Clinical Research Associate
$88K - $105K *
Empower study teams by overseeing clinical site management, ensuring compliance, and enhancing investigation quality through proactive monitoring and support. Collaborate effectively to drive study su...
Reposted yesterday
$140K - $175K *
Shape the future of electrical testing by leading technical initiatives, mentoring specialists, and enhancing test processes to ensure quality and efficiency in production. Collaborate across teams to...
1 week ago
$140K - $175K *
Lead the charge in advancing electrical test processes, establishing best practices, and mentoring a team of Test Specialists. Collaborate with cross-functional teams to ensure robust testing and qual...
1 week ago
Specialist - Manufacturing - Engineering Support
$107K - $145K *
Build and maintain crucial documentation and quality records to enhance manufacturing processes and ensure compliance in a GMP environment while collaborating across teams to drive continuous improvem...
Reposted 3 weeks ago
Senior Manager, Quality Engineering - Manufacturing Operations
$110K - $130K *
Champion quality excellence by leading and developing a team of Quality Engineers to ensure compliance and operational performance in a regulated manufacturing environment, driving continuous improvem...
3 weeks ago
$140K - $150K *
Join a team that's dedicated to advancing clinical research by managing complex studies, ensuring compliance with regulations, and leading cross-functional teams to achieve project milestones efficien...
1 week ago
$164K - $190K *
Lead the charge in managing complex DoD acquisition programs, utilizing advanced analytical techniques to ensure efficiency and effectiveness. Collaborate with senior management to deliver strategic s...
1 week ago
$110K - $130K *
Unlock potential by leading program management initiatives for full-spectrum security operations. Collaborate with stakeholders to ensure effective execution of projects, budgets, and strategic commun...
1 week ago
What does a senior regulatory affairs specialist do?
A senior regulatory affairs specialist interprets applicable regulations, develops or supports regulatory strategies, coordinates submissions and documentation, and advises cross-functional teams on compliance throughout a product's lifecycle.
What qualifications are commonly required for senior regulatory affairs specialist jobs?
Employers commonly seek relevant regulatory affairs experience, familiarity with regulations for the applicable industry and markets, strong written communication, project-management ability, and a related degree. Specific requirements vary by role and product area.
Which industries hire senior regulatory affairs specialists?
Common employers include pharmaceutical, biotechnology, medical device, and diagnostics companies, as well as other organizations that develop or manage regulated products.
How much do senior regulatory affairs specialist jobs pay?
Pay varies by employer, location, industry, and experience. Ladders focuses on vetted professional jobs paying $100,000 or more.
What career paths can follow a senior regulatory affairs specialist role?
Experienced specialists may advance into regulatory strategy, regulatory program or operations leadership, management, or related quality and compliance roles, depending on their background and the employer.