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 Proposal Management Analyst
$95K - $115K *
Transform proposal development by collaborating with diverse teams to manage logistics, maintain configuration control, and ensure timely delivery of high-quality proposals for federal government oppo...
1 week ago
Senior Reliability Test Engineer - Environmental Simulation Lab
$83K - $114K *
Transform product testing by leading environmental simulations, ensuring compliance with standards, and optimizing lab efficiency. Collaborate with teams to develop test plans, analyze data, and enhan...
2 weeks ago
Senior Reliability Test Engineer - Environmental Simulation Lab
$83K - $114K *
Lead the charge in environmental testing by developing and executing test plans, ensuring compliance with standards, and optimizing lab operations. Collaborate with teams to enhance reliability and ef...
2 weeks ago
$110K - $130K *
Empower regulatory compliance by leading licensing activities for nuclear fuel fabrication. Collaborate with cross-functional teams to develop documentation, support safety analyses, and ensure alignm...
3 weeks ago
$80K - $95K *
Unlock potential by leading a dynamic research team, ensuring compliance, and driving successful clinical trials from initiation to closeout while fostering collaboration with sponsors and staff...
Reposted 2 weeks ago
Clinical Research Associate II - MedTech
$90K - $150K *
Lead the charge in site management by conducting monitoring visits, ensuring protocol adherence, and facilitating communication for effective project execution in clinical trials...
3 weeks ago
Senior Clinical Project Manager
$110K - $130K *
Champion the execution of global clinical trials, ensuring timely delivery and compliance. Lead cross-functional teams and manage vendor relationships to drive project success while adhering to regula...
2 weeks ago
Senior Clinical Science Specialist, Rare Disease / Liver, Allentown PA
$135K - $198K *
Drive strategic outcomes as a Senior Clinical Science Specialist, leveraging clinical expertise and data to manage complex accounts and engage diverse stakeholders. Achieve regional performance target...
3 weeks ago
Senior Principal Contract Administrator
$112K - $176K *
Analyze complex contracts and lead negotiations to ensure compliance and fulfillment. Collaborate with customers and internal teams to manage contract activities, mitigate risks, and support financial...
Reposted 1 week ago
Senior Principal Contract Administrator
$112K - $176K *
Lead the charge in contract administration, proposal preparation, and negotiation. Collaborate with customers to ensure compliance and fulfillment of contractual obligations while managing complex iss...
Reposted 1 week ago
Senior Principal Contract Administrator
$112K - $176K *
Lead the charge in managing complex contracts, ensuring compliance and fulfillment while interfacing with customers. Drive proposal preparation, negotiations, and administration to support organizatio...
Reposted 1 week ago
Senior Process Engineer - Reagent Process Development
$115K - $120K *
Drive innovation by transforming reagent chemistries into scalable manufacturing processes. Lead cross-functional teams in process development, validation, and technology transfer to enhance product d...
2 days ago
Senior Specialist Change Management (Hybrid)
$72K - $120K *
Champion change management initiatives by collaborating with teams to enhance processes, ensure compliance, and deliver training. Drive continuous improvement in the RAQA Division while supporting aud...
3 days ago
$95K - $115K *
Drive quality excellence as a Senior Quality Engineer, leading initiatives and mentoring teams to ensure compliance with regulatory standards throughout the product lifecycle. Collaborate on design an...
4 days ago
Senior Principal Contract Administrator
$112K - $168K *
Drive success in contract management as you negotiate and administer contracts, ensuring compliance while collaborating with diverse teams on critical programs. Take ownership of customer relationship...
Reposted 1 week ago
Quality Engineer Specialist - Semiconductor / Electronics
$124K - $151K *
Unlock potential by integrating quality principles into the design and development of innovative electronic and semiconductor products. Collaborate with cross-functional teams to ensure robust quality...
5 days ago
$105K - $126K *
Lead and optimize subcontract management by negotiating agreements, ensuring compliance, and collaborating with stakeholders to drive successful federal contracting outcomes while mentoring junior sta...
2 weeks ago
Sr. Director, Research and Development Quality Assurance
$239K - $295K *
Elevate your career by leading strategic GCP/GLP/GVP Quality Operations, driving continuous improvement in research quality processes, and collaborating across departments to ensure compliance and exc...
2 weeks ago
$118K - $155K *
Join a dynamic team to analyze and ensure compliance with environmental regulations impacting water and wastewater treatment. Collaborate with stakeholders to navigate complex regulatory landscapes an...
4 days ago
$118K - $155K *
Join a team that's dedicated to ensuring regulatory compliance in the water and wastewater treatment industry. This role involves research, analysis, and advising on regulatory impacts, while fosterin...
4 days ago
Senior Director, Licensing Officer - Oncology
$220K - $330K *
Drive strategic licensing initiatives in Oncology by leveraging deep scientific expertise and commercial acumen. Collaborate with cross-functional teams to assess opportunities, lead due diligence, an...
3 days ago
Quality Systems Engineer - CAPA and Process Improvement
$80K - $95K *
Drive quality excellence by managing CAPA processes and ensuring compliance with regulatory standards. Collaborate with cross-functional teams to enhance quality systems and foster continuous improvem...
3 days ago
Senior Production Control Support Analyst - LHA
$80K - $95K *
Drive strategic decision-making by analyzing production metrics and supporting the Navy's LHA project team. Engage with stakeholders to optimize workflows and ensure alignment across shipbuilding prog...
2 weeks ago
Senior Production Control Support Analyst - LHA
$80K - $95K *
Unlock potential by driving strategic decisions through advanced data analysis and production support for Navy shipbuilding projects, ensuring alignment and effective communication across teams and st...
2 weeks ago
Principal/Sr Principal Contract Administrator - 12902-1
$94K - $176K *
Empower success by managing complex contracts, ensuring compliance, and fostering strong customer relationships. Collaborate on proposals and negotiations while developing solutions to contractual cha...
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.