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.
Associate Principal Scientist, Clinical Research
$142K - $224K *
Join a team that's redefining early clinical development by leading innovative immunology trials. Drive excellence in execution, compliance, and data quality while mentoring junior staff and collabora...
5 days ago
Quality Engineer III - Sterilization
$100K - $120K *
Optimize sterilization processes and environmental controls for medical products, ensuring compliance with quality and regulatory standards. Lead validation activities and provide technical expertise...
3 weeks ago
Quality Engineer III - Sterilization
$100K - $120K *
Champion quality assurance by leading sterilization validation and compliance efforts. Collaborate across functions to ensure medical products meet rigorous standards, while driving continuous improve...
3 weeks ago
Quality Engineer III - Sterilization
$100K - $120K *
Lead specialized technical initiatives in sterility assurance and environmental controls, ensuring compliance with quality and regulatory standards. Collaborate across functions to validate sterilizat...
3 weeks ago
Quality Engineer III - Sterilization
$100K - $120K *
Elevate quality assurance in medical products by leading sterilization validation, ensuring compliance, and driving technical projects. Collaborate across functions to enhance processes and support pr...
3 weeks ago
Quality Engineer III - Sterilization
$100K - $120K *
Lead specialized technical initiatives in sterility assurance and environmental controls, ensuring compliance and validation for medical products. Collaborate across functions to enhance sterilization...
3 weeks ago
Senior Process Engineer - Liquid Systems
$100K - $120K *
Champion the design and execution of innovative liquid processing systems in the food and beverage sector, managing projects from scope to delivery while collaborating with diverse teams and mentoring...
3 days ago
Principal Regulatory & Product Compliance Engineer
$135K - $169K *
Transform regulatory approval processes for innovative products by collaborating with cross-functional teams and regional regulators, ensuring compliance and optimizing local approvals for market read...
2 weeks ago
$163K - $186K *
Transform clinical research by leading global early phase trials, ensuring compliance and optimizing strategies. Collaborate with cross-functional teams to drive study success and enhance patient outc...
2 weeks ago
Senior Manager, Clinical Data Management, Study Lead
$134K - $219K *
Empower data management excellence by leading cross-functional teams, ensuring compliance, and driving process improvements across multiple clinical trials while mentoring staff and maintaining high d...
4 days ago
Senior Patent Agent- Biologics
$136K - $186K *
Empower innovation by providing expert intellectual property support for Biologics R&D. Collaborate cross-functionally to draft and prosecute patents, ensuring alignment with global strategies and adv...
2 weeks ago
$89K - $134K *
Shape quality leadership for product lifecycle in a dynamic engineering environment. Collaborate with cross-functional teams to ensure compliance with quality standards and drive continuous improvemen...
4 days ago
$80K - $95K *
Unlock potential by driving supplier quality through APQP, audits, and continuous performance monitoring. Collaborate cross-functionally to enhance production flow and ensure zero defects in critical...
3 weeks ago
$88K - $105K *
Join us in driving excellence in supplier quality through advanced planning and validation. Collaborate cross-functionally to ensure zero defects and optimize production flow, while leading continuous...
3 weeks ago
Senior Quality Systems Engineer
$85K - $161K *
Shape the future of quality management by leading initiatives that enhance compliance and operational efficiency. Collaborate cross-functionally to drive continuous improvement and mentor teams in a d...
2 weeks ago
$110K - $120K *
Advance quality assurance practices by defining and implementing strategies that enhance software reliability and performance. Collaborate with cross-functional teams to ensure compliance and drive co...
2 days ago
Senior Project Manager - Medical Devices
$110K - $130K *
Lead the charge in managing innovative medical device projects, ensuring adherence to budget and timelines while driving teams to meet high-quality standards and client satisfaction. Oversee multiple...
4 weeks ago
Senior Project Manager - Medical Devices
$110K - $130K *
Lead the charge in delivering innovative medical devices by managing complex projects from conception through commercialization while ensuring adherence to timelines, budgets, and quality standards in...
4 weeks ago
Medical Affairs Program Manager
$108K - $150K *
Shape the future of clinical documentation by driving innovation and compliance in medical affairs. Collaborate across teams to generate evidence, support product activities, and ensure adherence to g...
1 week ago
Field Application Specialist (Chrom/TFF Systems)- Mid-Atlantic /Southeast
$90K - $116K *
Transform customer success as a Field Applications Specialist, providing expert support in downstream processing technologies. Collaborate with clients and internal teams to optimize workflows and enh...
1 week ago
Field Application Specialist (Chrom/TFF Systems)- Mid-Atlantic /Southeast
$90K - $116K *
Transform customer success as a Field Applications Specialist, providing expert support in downstream processing technologies. Collaborate with clients and internal teams to optimize workflows and enh...
1 week ago
Field Application Specialist (Chrom/TFF Systems)- Mid-Atlantic /Southeast
$90K - $116K *
Champion innovative downstream processing solutions by providing expert application support and technical guidance to customers, ensuring successful implementation and optimization of bioprocessing te...
1 week ago
Senior Electrical Physical Designer 1 - Nuclear
$77K - $118K *
Join a dynamic team to enhance your drafting skills while collaborating on design projects. Utilize advanced CAD tools and gain hands-on experience in 3D design, contributing to innovative solutions i...
2 weeks ago
Senior Electrical Physical Designer 1 - Nuclear
$77K - $118K *
Join us to leverage your drafting skills in a dynamic team, enhancing design projects and collaborating across disciplines to deliver high-quality technical drawings while receiving hands-on training...
4 weeks ago
Quality Engineer 3, Design Assurance
$100K - $150K *
Drive quality assurance initiatives throughout product development, ensuring compliance with industry standards. Collaborate cross-functionally to enhance design processes, manage risks, and support r...
3 days 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.