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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$190K - $220K *

Join a team that's shaping the future of global clinical trials by providing expert legal guidance on commercial transactions, regulatory compliance, and continuous improvement of legal processes whil...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$190K - $220K *

Lead the legal function by managing commercial agreements and advising on compliance. Collaborate with business teams to ensure rapid deal execution while mitigating risks. Drive process improvements...

Johnson City, TNRemote

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$100K - $152K *

Unlock your potential by working in a collaborative team to design, analyze, and improve complex control systems in nuclear power plants, focusing on innovative solutions and critical project executio...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$80K - $95K *

Empower compliance excellence across Latin America by partnering with stakeholders to mitigate risks and drive ethical business practices. Support the implementation of compliance initiatives while na...

3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$250K - $280K *

Transform our Quality Assurance landscape by leading a high-performing team, ensuring compliance across GxP functions, and driving strategic quality initiatives that align with corporate objectives an...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$134K - $219K *

Empower clinical laboratory operations by managing projects across therapeutic areas, ensuring timely study starts and data delivery while collaborating with cross-functional teams to mitigate risks a...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$134K - $219K *

Join a team that's driving innovation in clinical laboratory project management, ensuring timely delivery of laboratory services across therapeutic areas while collaborating with cross-functional team...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$134K - $219K *

Transform clinical laboratory operations by managing projects across therapeutic areas, ensuring timely study starts and data delivery while collaborating with cross-functional teams to mitigate risks...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$140K - $190K *

Unlock your potential by engaging key Gastroenterology stakeholders, driving product utilization, and exceeding sales goals through strategic collaboration and compliance in a dynamic healthcare envir...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $90K *

Champion quality and food safety by enhancing compliance and systems management. Collaborate across functions to ensure effective integration of quality standards and continuous improvement in a dynam...

4 days ago

  •   Less than 5 years exp.  •   Food & Beverages

$125K - $135K *

Shape public policy by advocating for key issues in Congress and the Executive branch. Build strategic relationships, analyze legislative impacts, and lead initiatives that enhance ASME's influence in...

4 days ago

  •   5 - 7 years exp.  •   Technical Services

$80K - $95K *

Lead the charge in managing multiple complex projects, ensuring timely deliverables through collaboration with cross-functional teams to enhance operational efficiency and drive improvements in the me...

Reposted 3 days ago

  •   5 - 7 years exp.  •   Healthcare

$84K - $126K *

Drive quality compliance through planning and executing audits, collaborating with teams to address compliance gaps, and managing corrective actions. Ensure readiness for inspections and maintain vend...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$127K - $191K *

Play a key role in leading a multi-year R&D program, managing five interdependent projects from development to launch. Collaborate across functions to ensure alignment and successful execution, drivin...

2 weeks ago

  •   5 - 7 years exp.  •   Consumer Technology

$86K - $165K *

Unlock potential by leading contract management for complex defense programs. Collaborate with cross-functional teams to drive proposal execution and maintain strong customer relationships, ensuring c...

Arizona, USRemote

2 weeks ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$80K - $95K *

Shape the future of operational excellence by leading regional teams, collaborating globally, and ensuring timely execution of projects while driving continuous improvements for enhanced productivity...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $120K *

Transform military systems by leading a multidisciplinary team in the design, development, and testing of embedded systems, ensuring compliance with customer requirements throughout the program lifecy...

Yesterday

  •   Less than 5 years exp.  •   Information Technology

$95K - $115K *

Lead systems engineering efforts for safety-critical avionics software, ensuring compliance with DO-178C standards. Collaborate with cross-functional teams to define, analyze, and manage requirements...

Yesterday

  •   5 - 7 years exp.  •   Information Technology

$110K - $130K *

Lead the charge in managing solid rocket motor technology projects, ensuring effective execution and collaboration across teams. Drive industrial base analysis and sustainment planning to enhance prop...

2 days ago

  •   5 - 7 years exp.  •   Information Technology

$120K - $160K *

Elevate your career by managing solid rocket motor technology projects, conducting industrial base analyses, and collaborating with stakeholders to enhance propulsion systems. This role combines engin...

2 days ago

  •   5 - 7 years exp.  •   Information Technology

$140K - $180K *

Unlock the potential of intelligence systems integration by leading efforts to ensure seamless interoperability across multi-discipline analysis platforms, enhancing operational readiness and data-dri...

4 days ago

  •   Less than 5 years exp.  •   Information Technology

$110K - $130K *

Shape the future of military intelligence by leading system integration efforts, ensuring seamless interoperability of advanced analytics and data platforms to enhance operational readiness and decisi...

5 days ago

  •   8 - 10 years exp.  •   Information Technology

$110K - $130K *

Support critical integration tasks and troubleshoot workflows to enhance data sharing and interoperability within Army intelligence systems, ensuring seamless operations and modernization efforts...

5 days ago

  •   5 - 7 years exp.  •   Information Technology

$110K - $130K *

Lead the charge in advancing terrestrial sensor integration for Army intelligence, ensuring seamless operational capabilities and strategic alignment across multiple defense sectors. Drive innovation...

5 days ago

  •   Less than 5 years exp.  •   Information Technology

$120K - $160K *

Elevate systems engineering excellence by leading critical activities for a high-priority defense program. Collaborate with multidisciplinary teams to deliver innovative solutions that meet stringent...

1 week ago

  •   5 - 7 years exp.  •   Information Technology

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.