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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$155K - $171K *

Shape strategic solutions by leading research and analyses, presenting insights, and driving project success. Collaborate with teams to deliver client-ready recommendations while fostering a high-perf...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$155K - $171K *

Lead transformative consulting projects by conducting in-depth research and presenting strategic recommendations. Collaborate with clients and junior team members to drive high-quality deliverables an...

Chicago, ILRemote

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$105K - $190K *

Empower progress at a dynamic program by managing complex hardware and software procurements. Collaborate with cross-functional teams to ensure timely delivery and maintain operational efficiency in a...

2 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$105K - $190K *

Shape the future of procurement by managing hardware and software assets in a dynamic, mission-focused environment. Collaborate with cross-functional teams to streamline processes and ensure timely de...

2 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$100K - $120K *

Join us to shape compliance strategies by analyzing taxpayer behavior and risks. Leverage data analytics and research to enhance compliance frameworks, ensuring effective risk management and promoting...

3 days ago

  •   8 - 10 years exp.  •   Education, Government & Non-Profit

$81K - $122K *

Join a team that's dedicated to ensuring compliant and efficient customs operations across North America. You'll manage customs clearance, perform audits, and support trade compliance initiatives whil...

4 days ago

  •   Less than 5 years exp.  •   Healthcare

$81K - $122K *

Shape the future of trade compliance by ensuring timely customs clearance and accurate HTS classification. Collaborate with cross-functional teams to uphold compliance standards and support operationa...

5 days ago

  •   Less than 5 years exp.  •   Healthcare

$95K - $115K *

Join a team that's dedicated to advancing pharmaceutical development. This role focuses on formulation and process design for oral solid dosage forms, ensuring compliance and quality in clinical trial...

3 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$160K - $190K *

Lead the development and implementation of global regulatory strategies, ensuring compliance and market approval for products. Collaborate with cross-functional teams to mitigate risks and drive regul...

Today

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$160K - $190K *

Shape global regulatory strategies in neuroscience. Oversee market approvals, manage cross-functional teams, and mitigate risks while ensuring compliance. Leverage your leadership and drug development...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$160K - $190K *

Optimize global regulatory strategies to secure market approval for neuroscience products. Lead cross-functional teams, anticipate regulatory risks, and ensure compliance while managing projects throu...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$160K - $190K *

Help us shape the future of global regulatory strategy in neuroscience. Lead cross-functional teams, develop innovative strategies, and ensure compliance for drug products throughout their lifecycle w...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Advance your career by managing procurement for large EPC projects. Negotiate supplier terms, drive cost efficiencies, and collaborate with cross-functional teams to ensure timely material flow and pr...

5 days ago

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

$145K - $205K *

Lead critical safety data exchange initiatives, ensuring compliance and high quality in pharmacovigilance partnerships. Collaborate with global partners to enhance operational governance and improve p...

Raleigh, NCRemote

4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$91K - $163K *

Champion regulatory initiatives that align with organizational goals, enhance compliance, and drive operational excellence. Collaborate across teams to deliver effective strategies and impactful solut...

Irvine, CARemote

Reposted 2 days ago

  •   5 - 7 years exp.  •   Healthcare

$164K - $180K *

Shape the future of clinical regulatory strategy by leading submission preparations and ensuring compliance with Health Authority requirements. Collaborate with cross-functional teams to provide exper...

5 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $142K *

Lead and coordinate construction management for capital projects, ensuring on-time delivery, budget compliance, and stakeholder communication from initiation to closure across multiple concurrent proj...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$77K - $118K *

Champion the design and development of electrical systems, leading multi-disciplinary teams to create innovative solutions. Utilize advanced modeling software to ensure high-quality deliverables while...

3 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$100K - $120K *

Transform plant operations by leading technical initiatives in design, construction, and commissioning. Collaborate with multidisciplinary teams to ensure safe, reliable, and efficient plant startup a...

3 weeks ago

  •   8 - 10 years exp.  •   Energy & Utilities

$110K - $130K *

Drive the continuous enhancement of the Aseptic Observer Program, ensuring compliance and quality in sterile manufacturing operations, while fostering teamwork and adherence to safety and quality stan...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$115K - $130K *

Lead the charge in managing complex legal matters, supporting attorneys through litigation phases, and enhancing case management efficiency while ensuring high-quality outcomes and effective communica...

1 week ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$130K - $140K *

Champion the quality assurance of embedded medical devices by leading testing processes, ensuring compliance with regulatory standards, and driving continuous improvement in a collaborative environmen...

Yesterday

  •   8 - 10 years exp.  •   Information Technology

$74K - $104K *

Champion labeling initiatives by collaborating cross-functionally to enhance product delivery and compliance in the medical device industry, ensuring quality and efficiency in labeling processes while...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$100K - $125K *

Unlock potential by driving product safety and regulatory compliance efforts globally. Join a dynamic team to lead compliance strategy, streamline operations, and ensure safe product stewardship throu...

Reposted 2 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$120K - $145K *

Transform the RLD360 platform by defining user experiences and translating data capabilities into AI-driven products that enhance safety and compliance, while identifying new market opportunities and...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

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.