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.
$88K - $121K *
Drive quality excellence by ensuring compliance and effectiveness in quality systems. Collaborate across teams to manage investigations, audits, and product release, while supporting continuous improv...
Yesterday
Regulatory Affairs Specialist – Abbott Medical Devices (Mississauga)
$75K - $111K *
Transform the regulatory landscape by preparing applications and ensuring compliance with Canadian medical device regulations while collaborating across teams to drive project success and maintain hig...
6 days ago
$85K - $100K *
Champion quality assurance excellence in cGMP manufacturing, ensuring compliance and product integrity. Engage in diverse QA tasks, from documentation to inspections, while driving continuous improvem...
2 days ago
$85K - $100K *
Unlock potential by overseeing quality assurance activities in cGMP manufacturing. Drive compliance and excellence in documentation, product disposition, and quality systems while collaborating on pro...
2 days ago
Senior Technical Sales Specialist - Cell and Gene Therapy
$110K - $130K *
Transform your career by driving high-impact opportunities through advanced technical selling and market development. Collaborate with Central Sales to shape customer workflows and accelerate adoption...
1 week ago
Senior Technical Sales Specialist - Cell and Gene Therapy
$120K - $145K *
Join us to drive high-impact opportunities through advanced technical selling and market development. Collaborate with Central Sales to shape customer workflows, enhance adoption, and create strategic...
1 week ago
Sr. Quality Assurance Specialist
$103K - $181K *
Partner with us to oversee and maintain Quality Management Systems, ensuring compliance across multiple locations while driving continuous improvement and supporting quality operations in a regulated...
Reposted 1 week ago
Quality Assurance Specialist - Document Control
$85K - $95K *
Join a team that's dedicated to enhancing quality management systems by overseeing document control, training records, and compliance. Collaborate with cross-functional teams to ensure accuracy and in...
4 days ago
$150K - $180K *
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...
3 weeks ago
$95K - $115K *
Lead compliance excellence by conducting quality reviews, enhancing processes, and providing expert guidance to ensure timely, accurate client service and adherence to regulatory standards in a dynami...
5 days ago
Senior Director, Regulatory Affairs
$175K - $210K *
Lead the charge in developing and executing global regulatory strategies for innovative therapeutics. Collaborate with cross-functional teams to navigate regulatory pathways and ensure compliance from...
3 weeks ago
Quality Assurance Systems Specialist
$80K - $95K *
Elevate your career by leading equipment qualification and validation initiatives. Ensure compliance with GxPs and drive Data Integrity culture across the site while collaborating with cross-functiona...
1 week ago
$120K - $150K *
Elevate your career by leading regulatory strategy and compliance for diverse product portfolios. Collaborate cross-functionally to ensure successful product launches and ongoing compliance in domesti...
2 weeks ago
Senior Field Actions Specalist
$103K - $142K *
Join a dynamic team to enhance global field action compliance, ensuring regulatory adherence and patient safety. Leverage your expertise in post-market quality to drive continuous improvement and coll...
2 weeks ago
Senior Principal Scientist, Regulatory Liaison
$190K - $300K *
Lead the charge in developing global regulatory strategies for innovative immunology programs. Drive product approval processes, ensuring compliance and optimal labeling while managing complex project...
2 weeks ago
Senior Director (Sr Principal Scientist), Regulatory Liaison
$190K - $300K *
Unlock potential by leading global regulatory strategies for innovative immunology programs. Drive product approval timelines and collaborate with cross-functional teams to ensure compliance and optim...
Reposted yesterday
Lead - Biomanufacturing Compliance - Investigator, Deviations
$95K - $115K *
Empower compliance excellence by authoring deviation records and cGMP documents. Collaborate with teams to enhance inspection readiness and foster a culture of continuous improvement in biomanufacturi...
2 weeks ago
Associate Director, Regulatory Affairs US Advertising and Promotion - Immunology
$145K - $175K *
Lead the charge in regulatory strategy for advertising and promotion in immunology. Collaborate with cross-functional teams to drive initiatives, analyze market trends, and enhance processes while ens...
5 days ago
Associate Director, Regulatory Affairs US Advertising and Promotion - Immunology
$145K - $175K *
Join a team that's shaping the future of regulatory affairs by leading cross-functional initiatives in advertising and promotion. Leverage your expertise to drive strategic decisions and enhance commu...
5 days ago
Associate Director, Regulatory Affairs US Advertising and Promotion - Immunology
$138K - $165K *
Unlock your potential by leading cross-functional teams in regulatory affairs, driving strategic initiatives, and leveraging industry knowledge to enhance advertising and promotion practices in the im...
5 days ago
Director, 211 Manufacturing Quality and Regulatory Affairs
$190K - $228K *
Drive enterprise Quality and Regulatory governance for U.S. operations, ensuring compliance with FDA regulations and overseeing manufacturing quality in the therapeutic radiopharmaceutical sector whil...
Reposted 1 week ago
Lead Supplier Quality Specialist
$80K - $95K *
Lead the charge in ensuring supplier quality compliance through inspections, audits, and continuous improvement initiatives. Collaborate with suppliers to uphold standards and enhance production proce...
Yesterday
Global Regulatory Affairs Scholar
$76K - $121K *
Pioneer the future of global regulatory affairs through a two-year fellowship, gaining hands-on experience across diverse therapeutic areas while collaborating with industry leaders to enhance your pr...
Today
Global Regulatory Affairs Scholar
$76K - $121K *
Transform your career in regulatory affairs through a dynamic two-year fellowship, gaining hands-on experience across diverse therapeutic areas while collaborating with industry leaders to shape the f...
Today
Global Regulatory Affairs Scholar
$76K - $121K *
Champion innovative drug development by engaging in a two-year fellowship, gaining hands-on experience in regulatory affairs, and collaborating with experts to influence health authority strategies an...
Today
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.