Senior Regulatory Affairs Specialist Jobs

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.

What Senior Regulatory Affairs Specialists Do

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.

Common Responsibilities and Skills

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.

Industries and Career Opportunities

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.

Find Senior Regulatory Affairs Specialist Jobs

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.

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$80K - $95K *

Transform government contracts management by ensuring compliance and quality in Medicaid, Medicare, and Marketplace programs. Collaborate across teams to support low-income populations and maintain re...

2 days ago

  •   Less than 5 years exp.  •   Healthcare

$80K - $95K *

Champion government contracts activities by ensuring compliance and quality in Medicaid, Medicare, and Marketplace programs. Collaborate with state agencies and internal teams to support health care s...

2 days ago

  •   Less than 5 years exp.  •   Healthcare

$163K - $186K *

Partner with us to drive excellence in external manufacturing, overseeing supplier relationships and ensuring high performance across cross-functional teams. Leverage your expertise in pharmaceutical...

5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$163K - $186K *

Optimize supplier relationships and oversee manufacturing activities to ensure high performance and compliance in pharmaceutical production. Lead cross-functional teams to achieve business objectives...

5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$63K - $123K *

Join a team that's dedicated to ensuring product quality through rigorous inspections and audits. Collaborate with engineering and operations to implement quality assurance programs and drive continuo...

2 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$95K - $115K *

Elevate compliance and quality assurance standards by managing GxP projects, providing expert consultation, and driving continuous improvement in regulatory practices. Collaborate with clients to ensu...

3 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$151K - $241K *

Lead and enhance Quality Assurance operations, ensuring compliance with cGMP and FDA regulations. Oversee quality systems, manage teams, and drive continuous improvement initiatives across manufacturi...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Shape the future of supplier performance by collaborating with cross-functional teams to enhance quality and delivery. Drive continuous improvement initiatives and conduct critical assessments to elev...

1 week ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$86K - $113K *

Elevate your career as you provide statistical support for study design and analysis, collaborating with experienced statisticians to enhance methodologies and improve project delivery in the pharmace...

Mississauga, ONIn-Person

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$100K - $130K *

Shape the future of cleanroom certification by leading technical operations, training personnel, and ensuring compliance with industry standards. Leverage your expertise to enhance service delivery an...

5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$85K - $130K *

Lead innovative mechanical design projects, collaborating with engineers and designers to create complex 3D models and systems. Take on challenging assignments, mentoring less experienced team members...

3 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$88K - $105K *

Champion quality excellence and customer engagement in high-tech manufacturing. Collaborate with cross-functional teams to drive continuous improvement, manage product qualifications, and resolve comp...

2 weeks ago

  •   5 - 7 years exp.  •   Business Services

$85K - $95K *

Elevate compliance standards by supporting the Investment Advisory Compliance Team. Engage with financial advisors and internal partners to address inquiries, interpret policies, and enhance operation...

2 days ago

  •   Less than 5 years exp.  •   Finance & Insurance

$85K - $95K *

Unlock your potential as a Senior Compliance Analyst, where you'll support investment advisory compliance, engage with financial advisors, and enhance operational initiatives in a collaborative enviro...

2 days ago

  •   Less than 5 years exp.  •   Finance & Insurance

$85K - $95K *

Optimize compliance processes in investment advisory services, ensuring adherence to regulations while supporting financial advisors and internal teams. Collaborate on projects and enhance operational...

2 days ago

  •   Less than 5 years exp.  •   Finance & Insurance

$85K - $95K *

Optimize compliance processes in investment advisory services. Collaborate with financial advisors and internal teams to ensure adherence to regulations while supporting operational initiatives and en...

2 days ago

  •   Less than 5 years exp.  •   Finance & Insurance

$110K - $130K *

Lead the charge in pharmaceutical product development, driving formulation and process innovation from early stages to clinical manufacturing. Collaborate across teams to ensure successful project exe...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$82K - $105K *

Support the resolution of complex technical issues for Materials Characterization platforms, enhancing customer experience and instrument uptime through expert diagnostics and remote troubleshooting...

RemoteRemote

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$120K - $145K *

Champion the integration of advanced laboratory systems by providing expert application support, training, and troubleshooting to enhance customer workflows and ensure successful adoption of innovativ...

2 days ago

  •   5 - 7 years exp.  •   Healthcare

$110K - $130K *

Lead clinical studies in infectious disease, ensuring scientific execution and collaboration with stakeholders. Oversee medical monitoring, trial design, and data management while mentoring junior sci...

Montreal, QCIn-Person

5 days ago

  •   Less than 5 years exp.  •   Healthcare

$100K - $120K *

Join a team that's redefining clinical research in infectious diseases. Lead studies, collaborate with stakeholders, and ensure scientific integrity while driving innovative trial designs and monitori...

Burlington, ONIn-Person

5 days ago

  •   Less than 5 years exp.  •   Healthcare

$110K - $130K *

Empower clinical research by leading studies in infectious diseases, ensuring scientific integrity and collaboration with stakeholders. Drive trial design, monitor data, and support medical activities...

RemoteRemote

6 days ago

  •   Less than 5 years exp.  •   Healthcare

$80K - $95K *

Unlock potential by leading sourcing strategies and managing supplier relationships to drive cost savings and enhance procurement processes across multiple categories in a dynamic environment...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Lead the Engineering Change process for complex scientific instruments, collaborating with cross-functional teams to evaluate, execute, and implement product changes throughout the lifecycle, ensuring...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Transform clinical compliance by ensuring alignment with healthcare regulations. This role offers a pathway to senior leadership, focusing on auditing, documentation quality, and risk assessment while...

1 week ago

  •   5 - 7 years exp.  •   Hospitals & Medical Centers

Frequently Asked Questions (FAQ)

  • What does a senior regulatory affairs specialist do?question toggle

    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?question toggle

    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?question toggle

    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?question toggle

    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?question toggle

    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.