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 *

Join a team that's committed to quality and compliance in product complaint handling. You will oversee end-to-end processes, ensuring accuracy and adherence to regulations while collaborating with cro...

1 month ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$93K - $128K *

Optimize research efficiency by managing chemical and biological samples. Collaborate with cross-functional teams to ensure sample integrity, accurate tracking, and timely distribution in a fast-paced...

4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$132K - $198K *

Join a team that's redefining compliance in SaaS security. As a Principal GCO High Compliance Systems Advisor, you'll lead FedRAMP authorization, manage technical controls, and ensure audit readiness...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$132K - $198K *

Shape high-compliance certification programs by leading FedRAMP authorization, managing technical controls, and ensuring audit readiness across multi-jurisdictional SaaS security operations. Collabora...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$132K - $198K *

Optimize high-compliance certification programs by leading FedRAMP authorization, managing technical controls, and collaborating with cross-functional teams to ensure audit readiness and regulatory co...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $100K *

Join a dynamic team to oversee analytical process development of proteins, optimizing in-process assays and enhancing lab efficiencies while delivering data-driven support and insights to stakeholders...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$98K - $148K *

Optimize quality assurance processes by leading investigations, managing nonconforming materials, and collaborating with vendors and engineering teams to enhance product quality and compliance with in...

Reposted 1 week ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$85K - $120K *

Join a dynamic team to manage legal processes, ensuring compliance and efficiency. You'll streamline operations, support attorneys, and leverage technology to enhance workflows, all while maintaining...

2 weeks ago

  •   Less than 5 years exp.  •   Finance & Insurance

$120K - $145K *

Partner with us to lead complex evaluations in nuclear reactor technology, ensuring safety and performance standards. Collaborate with experts to resolve technical challenges and provide authoritative...

4 days ago

  •   Less than 5 years exp.  •   Education, Government & Non-Profit

$100K - $120K *

Unlock your potential by providing senior-level acquisition support throughout the federal acquisition lifecycle. Collaborate with stakeholders to develop, award, and manage complex contracts, ensurin...

2 weeks ago

  •   8 - 10 years exp.  •   Business Services

$150K - $178K *

Pioneer a comprehensive Computer System Validation strategy across GxP systems. Collaborate with Quality and IT to drive compliance and data integrity while enhancing efficiency in validation processe...

United StatesRemote

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$93K - $155K *

Join a team that's advancing orthopedic technology through innovative modeling and simulation. Leverage your engineering expertise to drive research and development initiatives, enhancing product desi...

Reposted 3 days ago

  •   Less than 5 years exp.  •   Healthcare

$139K - $196K *

Lead the charge in electrical hardware design, managing R&D teams to deliver innovative solutions while ensuring project success through collaboration and mentorship across functions...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$88K - $119K *

Transform your career by driving the commissioning, qualification, and validation of GMP processes. Collaborate across teams to ensure compliance and efficiency in drug product operations, enhancing p...

5 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Transform supplier quality through robust process improvements, driving zero-defect initiatives and corrective actions. Collaborate with suppliers to enhance performance metrics and ensure compliance...

4 days ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$85K - $130K *

Unlock your potential in a dynamic role that merges mechanical design with project coordination. Collaborate with experts to create comprehensive mechanical layouts and ensure timely, high-quality pro...

4 weeks ago

  •   11 - 15 years exp.  •   Technical Services

$70K - $95K *

Drive the future of GHG emissions verification by leading audits, analyzing data, and ensuring compliance with industry standards. Collaborate with clients to enhance transparency and accuracy in emis...

Emeryville, CARemote

Yesterday

  •   Less than 5 years exp.  •   Energy & Utilities

$140K - $150K *

Shape your career by managing clinical research studies, ensuring compliance with regulations, and leading cross-functional teams to achieve project milestones efficiently and effectively...

Boston, MARemote

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$127K - $180K *

Shape the future of biologics by advancing analytical methods for therapeutic proteins using high-resolution mass spectrometry. Collaborate across teams to deliver high-quality results in a fast-paced...

Reposted 3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Elevate your career by engaging in cutting-edge analytical methods for cell and gene therapy. Collaborate with cross-functional teams to ensure compliance and innovate within a regulated environment...

1 month ago

  •   Less than 5 years exp.  •   Education, Government & Non-Profit

$110K - $130K *

Support critical quality oversight for validation activities in regulated environments by reviewing documentation and ensuring compliance with regulations and company standards while collaborating wit...

1 month ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$135K - $159K *

Lead the charge in transforming manufacturing processes through innovative automation solutions. Collaborate with experts to enhance workflows and drive technology integration in a cutting-edge drug s...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$74K - $138K *

Champion supplier compliance by overseeing nuclear quality assurance activities, ensuring adherence to procurement standards, and enhancing construction practices through effective monitoring and insp...

Yesterday

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

$77K - $129K *

Join a dynamic team to lead process engineering for new product launches, ensuring compliance and quality in manufacturing. Collaborate with cross-functional teams to develop efficient, scalable solut...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$74K - $118K *

Elevate compliance standards by leading oversight initiatives, managing complex projects, and collaborating across teams to ensure regulatory adherence and effective governance in a dynamic environmen...

United StatesRemote

Today

  •   5 - 7 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.