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.
Senior AI Product Manager – Government Pricing & Compliance
$130K - $155K *
Empower the future of government pricing by leading AI product initiatives that enhance compliance, optimize workflows, and ensure accuracy. Collaborate across teams to drive innovation from concept t...
Today
Senior AI Product Manager – Government Pricing & Compliance
$130K - $155K *
Explore your career by leading AI-driven solutions for government pricing and compliance. Collaborate across teams to enhance accuracy, optimize systems, and ensure regulatory adherence while managing...
Today
$83K - $155K *
Champion quality excellence in internal products and support new development. Drive audits, manage supplier quality, and improve standards to enhance reliability and performance across assigned areas...
3 weeks ago
Manager, Quality Engineering, Change Control/Document Review
$116K - $141K *
Lead quality engineering initiatives by managing change control processes, ensuring compliance, and driving continuous improvement across cross-functional teams. Serve as a subject matter expert to en...
3 days ago
Associate Director, Data Validation Strategy
$157K - $256K *
Champion the execution of integrated data review strategies, ensuring high-quality clinical data. Collaborate with cross-functional teams to drive innovation and continuous improvement in data managem...
2 weeks ago
Associate Director, Data Validation Strategy
$157K - $256K *
Lead the charge in developing and executing integrated data review strategies, ensuring high-quality clinical data. Collaborate with cross-functional teams to drive innovation and continuous improveme...
2 weeks ago
$95K - $115K *
Elevate product quality by leading quality assurance efforts in the medical device sector. Collaborate with cross-functional teams to ensure compliance, conduct risk assessments, and drive continuous...
2 weeks ago
Regulatory Manager - Sumitomo Biorational Company
$112K - $137K *
Lead the charge in regulatory strategy and registration management for biorational products, ensuring compliance and supporting global business objectives through expert guidance and strategic directi...
1 week ago
Associate Director, CMC Regulatory Affairs
$166K - $249K *
Lead the charge in executing global regulatory CMC strategies for investigational and marketed products, ensuring compliance and guiding cross-functional teams through complex regulatory landscapes...
Yesterday
Senior Pharmacovigilance (PV) Clinical Scientist
$120K - $224K *
Unlock potential by leading pharmacovigilance efforts to ensure patient safety and regulatory compliance. Collaborate with multidisciplinary teams, oversee vendor quality, and drive operational excell...
2 weeks ago
$80K - $95K *
Advance the future of validation engineering by leading complex projects, ensuring compliance with regulatory standards, and driving continuous improvement initiatives in pharmaceutical facilities and...
2 weeks ago
$92K - $149K *
Unlock your potential as a Quality Assurance Manager, overseeing compliance and quality functions. Drive continuous improvement, manage audits, and lead a team to ensure regulatory adherence and opera...
2 weeks ago
$90K - $110K *
Join a team that's dedicated to upholding quality standards and compliance. Lead quality assurance processes, engage in continuous improvement, and manage regulatory audits to ensure exceptional produ...
4 weeks ago
Senior Director Global Patient Safety
$242K - $403K *
Drive safety initiatives by leading pharmacovigilance activities, overseeing safety reports, and collaborating across teams to ensure patient safety and regulatory compliance. Influence strategies and...
Yesterday
$150K - $180K *
Join a team that's dedicated to ensuring product quality throughout the lifecycle. Lead compliance efforts, drive process improvements, and collaborate across functions to achieve excellence in design...
4 days ago
Associate Specialist, Engineering
$71K - $113K *
Innovate in early-career engineering by solving manufacturing challenges and enhancing packaging processes. Collaborate with cross-functional teams to support new product introductions and ensure comp...
2 weeks ago
Associate Specialist, Engineering
$71K - $113K *
Advance your engineering career by collaborating with cross-functional teams to tackle manufacturing challenges, enhance packaging processes, and support new product introductions in a dynamic, global...
2 weeks ago
Principal Scientist - Bioanalytical Outsourcing
$128K - $210K *
Drive bioanalytical excellence by overseeing CRO collaborations for PK, immunogenicity, and biomarker analysis, ensuring compliance with GLP/GCLP standards while managing assay development and reporti...
4 days ago
$119K - $186K *
Drive the charge in managing complex NPI projects, ensuring timely delivery and quality standards. Collaborate with cross-functional teams to optimize resources, mitigate risks, and enhance operationa...
1 week ago
Lead Specialist, QA Validation
$104K - $143K *
Join a team that's dedicated to ensuring cGMP compliance through expert QA oversight in commissioning, qualification, and validation activities. Lead a collaborative environment focused on continuous...
3 weeks ago
Senior Manager Corporate Quality Compliance
$138K - $187K *
Unlock your potential by leading global quality compliance initiatives, coordinating audits, training programs, and ensuring regulatory adherence to safeguard product integrity and drive organizationa...
4 weeks ago
Senior Manager, Quality Assurance, Regulatory & Compliance
$120K - $130K *
Champion quality and compliance in a dynamic environment, ensuring products meet global safety and regulatory standards. Lead quality control processes and collaborate cross-functionally to drive exce...
2 weeks ago
Senior Bioprocess Engineer - Cell Production & Process Development
$110K - $130K *
Elevate bioprocess engineering by leading the development and optimization of GMP-compliant cell production processes, ensuring high-quality cellular supply for research and clinical applications. Dri...
3 weeks ago
Clinical Research Associate II
$80K - $95K *
Optimize clinical research processes by conducting comprehensive monitoring visits, ensuring adherence to quality standards, and facilitating effective communication among project teams and sites acro...
Today
Senior Sales Specialist - High-Plex Sequencing
$140K - $180K *
Lead market growth as a High-Plex Sequencing Sales Specialist, leveraging deep NGS expertise to develop workflows, consult with customers, and drive strategic success in key market segments across a f...
3 weeks 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.