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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$95K - $115K *

Lead automation and digital transformation in manufacturing systems, ensuring reliability, compliance, and innovation through effective systems design, collaboration, and optimization of operations to...

Reposted 2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$105K - $130K *

Drive quality assurance excellence by collaborating across teams to elevate manufacturing standards and ensure products meet rigorous customer requirements, ultimately enhancing lives through superior...

3 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$119K - $222K *

Oversee Project Control activities, leading teams on medium to large projects. Drive implementation of control programs, analyze performance variances, and contribute to proposals while ensuring effec...

3 days ago

  •   11 - 15 years exp.  •   Real Estate & Construction

$100K - $120K *

Empower your career by driving product strategy and operations. Collaborate with cross-functional teams to enhance product development, market positioning, and operational efficiency while shaping the...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Lead the charge in shaping product strategy and operations, driving innovation and market success through collaboration with cross-functional teams. Own key initiatives in product development, plannin...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Join a team that's driving innovation in product strategy and operations. Collaborate across functions to enhance product development, market strategies, and operational efficiency while shaping the f...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$82K - $156K *

Drive global quality system excellence by overseeing compliance, enhancing digital tools, and fostering cross-functional collaboration to ensure effective quality performance and continuous improvemen...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$82K - $156K *

Join a team that's dedicated to enhancing patient safety and product quality by developing and maintaining quality engineering methodologies. Collaborate across functions to drive initiatives that mee...

Reposted 2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$110K - $130K *

Accelerate quality excellence by leading QA/QC initiatives across diverse projects. Oversee compliance, mentor teams, and enhance the Quality Management System to ensure superior project execution and...

1 week ago

  •   8 - 10 years exp.  •   Real Estate & Construction

$142K - $161K *

Join us to ensure the highest quality standards for our FDA-cleared AI clinical platform. Collaborate across teams to drive software design quality, manage regulatory compliance, and enhance post-mark...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$78K - $109K *

Partner with us to enhance quality systems by managing training, document control, and records management processes. Collaborate across teams to ensure compliance and efficiency in a regulated environ...

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$102K - $171K *

Shape the future of medical devices by leading quality engineering for new product introductions, ensuring compliance with regulatory standards and driving process improvements in a dynamic, collabora...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$85K - $125K *

Champion quality excellence in materials engineering by leading supplier development and performance improvement initiatives for polyurethane foams. Collaborate cross-functionally to ensure robust qua...

4 days ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$116K - $210K *

Transform environmental remediation projects as a technical leader, guiding multidisciplinary teams through complex regulatory challenges, and fostering collaboration with stakeholders to ensure compl...

United StatesRemote

3 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$155K - $214K *

Shape the future of food safety and quality by leading initiatives, managing cross-functional teams, and driving compliance with industry standards to enhance consumer experience and operational excel...

1 week ago

  •   8 - 10 years exp.  •   Food & Beverages

$210K - $215K *

Shape your future as you navigate complex legal frameworks, draft critical agreements, and guide senior management. This role offers the chance to directly influence compliance and risk management wit...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$210K - $215K *

Lead the charge in navigating complex legal landscapes, drafting contracts, and ensuring compliance. Collaborate closely with senior management to achieve business goals while mitigating risks and res...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$210K - $215K *

Join a team that's dedicated to navigating complex legal landscapes. In this role, you will manage contracts, advise on compliance, and support business strategies, ensuring both regulatory adherence...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$210K - $215K *

Lead the charge in managing legal matters, drafting agreements, and advising senior management. This role requires strong transactional experience to ensure compliance and mitigate risks while fosteri...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$210K - $215K *

Unlock potential by advising on complex legal matters, drafting agreements, and ensuring compliance to support business objectives while minimizing risks. Collaborate with senior management to address...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$122K - $212K *

Shape strategic legal counsel for government programs, navigating complex regulatory landscapes. Provide actionable advice to support business objectives while managing risks and ensuring compliance a...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$122K - $212K *

Champion innovative legal strategies in government procurement, providing expert counsel on compliance and regulatory matters. Drive enterprise impact through strategic advice, risk management, and co...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Champion environmental compliance by managing multi-media programs across multiple states. Lead air permitting, ensure regulatory adherence, and drive operational integration while collaborating with...

Yesterday

  •   5 - 7 years exp.  •   Energy & Utilities

$80K - $95K *

Take ownership of critical validation tasks for laboratory instruments and GMP equipment, ensuring compliance in a dynamic, regulated environment. Collaborate closely across teams to manage multiple p...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Champion high-quality medical writing deliverables across clinical research phases, ensuring compliance with regulatory standards while managing client expectations and leading cross-functional teams...

1 week ago

  •   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.