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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$150K - $190K *

Unlock potential by leading analytical strategies for drug development, ensuring robust quality control throughout product lifecycle. Collaborate with partners to deliver exceptional insights that dri...

United StatesRemote

Reposted 3 weeks ago

  •   8 - 10 years exp.  •   Information Technology

$100K - $125K *

Join a team that's dedicated to enhancing quality in aerospace and defense. Lead quality engineering initiatives, drive compliance with AS9100 standards, and foster continuous improvement across progr...

2 days ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$88K - $105K *

Elevate your career by leading tech transfer activities, driving formulation design, and optimizing processes for new pharmaceutical products while ensuring compliance with regulations and fostering t...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Unlock quality assurance excellence by driving compliance and safety in medical device manufacturing. Collaborate with cross-functional teams to enhance standards, analyze trends, and lead investigati...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$107K - $195K *

Unlock potential by leading the design and implementation of relay settings for utility substations and renewable energy projects, collaborating with engineers and clients to solve complex engineering...

RemoteRemote

2 weeks ago

  •   Less than 5 years exp.  •   Technical Services

$107K - $195K *

Empower utility projects by preparing relay settings and collaborating with engineers. Lead design efforts for substations and renewable energy, ensuring quality and compliance while solving complex e...

2 weeks ago

  •   Less than 5 years exp.  •   Technical Services

$107K - $195K *

Empower utility projects by preparing relay settings and collaborating with engineers. Lead design efforts for substations and renewable energy, ensuring quality and compliance while solving complex e...

2 weeks ago

  •   Less than 5 years exp.  •   Technical Services

$120K - $140K *

Champion innovative sales strategies to drive revenue growth and market expansion. Collaborate with a dedicated team to foster customer satisfaction and navigate competitive landscapes while leveragin...

4 weeks ago

  •   Less than 5 years exp.  •   Business Services

$120K - $140K *

Accelerate growth by developing innovative sales strategies while collaborating with teams to achieve revenue goals and enhance customer satisfaction in a dynamic digital pathology market...

4 weeks ago

  •   Less than 5 years exp.  •   Business Services

$120K - $140K *

Accelerate progress at driving sales strategies for revenue growth while ensuring customer satisfaction. Collaborate with a dedicated team and leverage CRM tools to achieve annual sales goals in your...

4 weeks ago

  •   Less than 5 years exp.  •   Business Services

$120K - $140K *

Champion innovative sales strategies to drive revenue growth and market expansion in assigned territory, fostering customer satisfaction and leveraging digital pathology solutions for exceptional resu...

4 weeks ago

  •   Less than 5 years exp.  •   Business Services

$110K - $130K *

Unlock potential by leading quality operations to ensure patient safety and compliance. Collaborate with cross-functional teams to drive continuous improvement and implement effective quality systems...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Support operational quality activities to ensure patient safety and reliable supply. Collaborate with cross-functional teams to simplify processes, drive continuous improvement, and lead quality initi...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$77K - $129K *

Explore a dynamic role in electrical engineering, focusing on innovative medical devices. Collaborate with cross-functional teams to design, develop, and validate electrical components that enhance pa...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$115K - $158K *

Drive compliance for medical devices with global environmental regulations, ensuring product safety and market access. Collaborate with teams to integrate compliance into design and documentation, whi...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Partner with us to drive compliance and operational excellence for the COSMIC-2 mission, ensuring seamless execution of international data exchanges while maintaining adherence to federal export contr...

4 weeks ago

  •   5 - 7 years exp.  •   Real Estate & Construction

$125K - $135K *

Manage and enhance the Quality Management System (QMS) to ensure compliance with regulatory standards and internal procedures, collaborating cross-functionally to drive quality initiatives and continu...

2 weeks ago

  •   5 - 7 years exp.  •   Retail & Consumer Goods

$85K - $100K *

Champion compliance excellence by reviewing retail communications to ensure adherence to regulations and firm policies. Collaborate with teams to maintain high standards and support organizational goa...

United StatesRemote

2 days ago

  •   5 - 7 years exp.  •   Finance & Insurance

$79K - $127K *

Lead the charge in establishing and maintaining quality assurance programs, ensuring compliance and continuous improvement through effective training and monitoring systems. Collaborate across functio...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Empower your career by leading court operations and legislative analysis. Collaborate with key stakeholders to implement best practices and support the Association's mission through effective communic...

1 week ago

  •   Less than 5 years exp.  •   Information Technology

$172K - $232K *

Lead the GCP Inspection Management team to ensure inspection readiness and compliance. Oversee strategy development, cross-functional collaboration, and risk mitigation for successful regulatory inspe...

United StatesRemote

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$175K *

Champion safety by identifying and mitigating risks in inspection tools. Lead design reviews, support testing, and communicate system risks to ensure compliance with safety standards and practices acr...

1 week ago

  •   8 - 10 years exp.  •   Staffing

$77K - $118K *

Join a team that's shaping nuclear energy solutions through technical design, drafting, and collaboration. Leverage your skills in a hybrid setting while contributing to innovative projects that influ...

4 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$77K - $118K *

Unlock potential by applying your advanced drafting skills in a collaborative team. You'll create detailed design drawings, assist experienced designers, and engage with vendors to ensure precision in...

4 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$83K - $154K *

Transform supplier quality oversight by applying nuclear standards and inspection techniques. Collaborate with project teams to ensure compliance, assess readiness, and document performance, while man...

Yesterday

  •   Less than 5 years exp.  •   Real Estate & Construction

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.