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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$110K - $130K *

Unlock your potential by leading UAT initiatives in a dynamic compliance-focused banking team. Collaborate across functions to enhance regulatory readiness and data quality while driving impactful cha...

Yesterday

  •   5 - 7 years exp.  •   Staffing

$84K - $129K *

Champion mechanical engineering excellence for nuclear plant modifications, coordinating multidisciplinary efforts and ensuring project success through effective management of scope, budget, and techn...

1 week ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Join a dynamic team to lead mechanical engineering for nuclear plant modifications, ensuring safe and efficient project execution. Collaborate across disciplines while managing scope, budget, and tech...

1 week ago

  •   5 - 7 years exp.  •   Technical Services

$100K - $120K *

Shape the future of nuclear energy by designing systems, leading projects, and collaborating with clients to enhance plant operations and modifications, ensuring safety and efficiency in a hybrid work...

2 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$100K - $120K *

Lead the design and modification of nuclear power plant systems, ensuring compliance with engineering standards. Collaborate with project teams and clients to deliver innovative solutions while managi...

2 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Lead mechanical engineering efforts for nuclear plant modifications, coordinating multidisciplinary activities and serving as a key technical interface. Manage project scope, budget, and schedule whil...

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$81K - $124K *

Optimize nuclear power plant systems design by leading engineering projects, preparing modification packages, and conducting technical evaluations to enhance operational efficiency and compliance with...

North York, ONIn-Person

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Contribute to nuclear power plant systems design by reviewing and preparing modification packages, functional drawings, and technical documents while leading engineering projects to enhance plant oper...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Partner with us to enhance nuclear power plant systems through design and evaluation, ensuring operational excellence and compliance with standards. Collaborate with teams to lead projects that suppor...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Transform nuclear power plant systems design by reviewing modifications and leading engineering projects. Collaborate with clients, develop cost estimates, and enhance operational safety and efficienc...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Engineer and optimize nuclear power plant systems through design, modifications, and analyses. Collaborate with teams and clients to enhance plant operations while ensuring safety and compliance with...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Join a team that's at the forefront of nuclear power engineering, working on design, analysis, and modification of systems to ensure optimal performance and compliance in operational plants. Drive inn...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Innovate within the nuclear power sector by leading design projects, evaluating modifications, and ensuring compliance with regulatory standards, while collaborating with clients to deliver efficient...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Drive innovative solutions in nuclear power plant design, focusing on modifications, analyses, and vendor evaluations while leading engineering teams to enhance operational efficiency in a hybrid work...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Join a team that's shaping the future of nuclear energy by designing systems and supporting modifications in power plants. Collaborate on engineering analyses, prepare technical documents, and lead pr...

1 month ago

  •   5 - 7 years exp.  •   Technical Services

$240K - $300K *

Drive supplier quality for liquid cooling and power delivery hardware, ensuring compliance with standards and reliability targets. Collaborate with cross-functional teams to enhance supplier performan...

Today

  •   5 - 7 years exp.  •   Information Technology

$110K - $130K *

Drive your career forward as a scientific leader in rheology and dynamic mechanical analysis. Collaborate across teams to develop innovative applications, support customers, and enhance product strate...

1 week ago

  •   5 - 7 years exp.  •   Consumer Technology

$95K - $115K *

Support robust federal acquisition processes by guiding complex procurements from planning through execution, ensuring compliance and efficiency while managing diverse contract types to meet organizat...

Reposted 6 days ago

  •   8 - 10 years exp.  •   Technical Services

$94K - $129K *

Reimagine proposal development by leading cross-functional teams to create competitive client solutions. This role combines project management, scientific insight, and strategic collaboration to drive...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$85K - $100K *

Pioneer quality excellence by developing and enhancing systems that elevate customer satisfaction, streamline processes, and ensure compliance across our manufacturing operations. Lead a dedicated tea...

1 week ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$86K - $116K *

Empower your career by supporting critical manufacturing operations, driving continuous improvement, and enhancing single-use systems. Collaborate with cross-functional teams to optimize processes and...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$143K - $210K *

Lead the charge in delivering strategic quality guidance, leveraging extensive engineering expertise to enhance product quality and compliance. Collaborate across teams to drive continuous improvement...

4 days ago

  •   8 - 10 years exp.  •   Healthcare

$159K - $251K *

Advance your career by leading innovative antibody discovery workflows. Collaborate with cross-functional teams to enhance automation and bioassay capabilities while managing a talented group of scien...

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Take ownership of clinical trial operations, leading Phase II/III studies from startup to closeout. Ensure compliance with regulations and GCP while managing cross-functional teams and vendor relation...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$112K - $168K *

Shape the future of cell therapy by leveraging your expertise in immunology and data analysis. Collaborate within multidisciplinary teams to drive innovative research and advance next-generation thera...

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

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.