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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$153K - $181K *

Champion innovative electrical design solutions, creating detailed models and drawings for diverse systems, including lighting and instrumentation. Collaborate on construction support and ensure compl...

1 week ago

  •   11 - 15 years exp.  •   Technical Services

$178K - $307K *

Unlock your potential by serving as a strategic legal leader in global regulatory matters for medical devices, collaborating with cross-functional teams to enable compliance, drive innovative strategi...

Reposted yesterday

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$125K - $150K *

Drive regulatory strategy and engagement for insurance, shaping the use of aerial imagery and AI in underwriting. Lead filing programs, collaborate with cross-functional teams, and ensure compliance w...

1 week ago

  •   8 - 10 years exp.  •   Enterprise Technology

$135K - $160K *

Champion regulatory strategy and lead insurance affairs, engaging with regulators and advising clients on AI and imagery use. Build a robust filing program and ensure compliance while shaping industry...

Lehi, UTRemote

1 week ago

  •   8 - 10 years exp.  •   Enterprise Technology

$100K - $152K *

Transform nuclear power plant operations by leading digital control system upgrades, enhancing process controls, and mentoring engineers to ensure optimal functionality and client satisfaction in a dy...

4 days ago

  •   5 - 7 years exp.  •   Technical Services

$100K - $152K *

Engineer innovative control systems for nuclear power plants, collaborating with project teams to design, troubleshoot, and enhance electrical controls. Drive project success through technical experti...

1 week ago

  •   5 - 7 years exp.  •   Technical Services

$140K - $153K *

Join a team that's dedicated to enhancing healthcare quality through innovative testing strategies. Collaborate with cross-functional teams to ensure robust, user-centered products while mentoring jun...

United StatesRemote

3 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$98K - $163K *

Unlock potential by enhancing data governance for a premier law enforcement client. Collaborate with teams to ensure compliance, improve data quality, and support enterprise integration initiatives wh...

2 weeks ago

  •   5 - 7 years exp.  •   Business Services

$132K - $178K *

Champion quality in In-Vitro Diagnostics and Companion Diagnostics. Lead proactive strategies, ensuring compliance in clinical trials while collaborating with partners to enhance precision medicine in...

United StatesRemote

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$71K - $169K *

Join us in leading the Quality Engineering team to enhance software testing processes, ensuring quality and reliability from strategy to release. Collaborate with cross-functional teams to drive autom...

3 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$71K - $169K *

Champion quality assurance by leading a global team through the software testing lifecycle. Drive automation strategies, enhance collaboration, and ensure timely delivery while mitigating risks and im...

3 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Lead the charge in ensuring quality compliance and readiness for audits and inspections. Oversee cross-functional teams, manage regulatory inspections, and foster a culture of excellence in quality sy...

Reposted 3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Drive quality excellence in aerospace manufacturing by leading a multi-level team, ensuring compliance with industry standards, and fostering a culture of continuous improvement and accountability to...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Aerospace & Defense

$84K - $129K *

Deliver innovative structural engineering solutions for industrial projects, guiding junior engineers and collaborating with teams to ensure design integrity and compliance with standards while addres...

2 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$160K - $215K *

Lead and innovate in medical product development, managing a diverse portfolio of projects. Collaborate with multidisciplinary teams to drive scientific objectives, ensure accountability, and navigate...

1 week ago

  •   15+ years exp.  •   Aerospace & Defense

$70K - $105K *

Unlock potential by providing exceptional support and training in clinical software, ensuring customer satisfaction through effective communication and problem-solving in a fast-paced environment. Joi...

United StatesRemote

2 weeks ago

  •   Less than 5 years exp.  •   Business Services

$205K - $256K *

Partner with us to lead strategic contract compliance and administration, driving operational excellence and revenue optimization across diverse functions. Champion AI and automation initiatives to en...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$146K - $194K *

Collaborate with design teams and suppliers to enhance quality processes, ensuring reliable hardware assemblies. Drive supplier engagement and quality readiness throughout product development, leverag...

2 weeks ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$146K - $194K *

Drive supplier quality processes to ensure high reliability and performance of components for advanced surveillance systems. Collaborate cross-functionally to enhance product quality and supplier perf...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$120K - $140K *

Champion compliance and innovation in avionics systems, ensuring adherence to airworthiness standards while driving upgrades and new product development in a collaborative environment...

Mirabel, QCIn-Person

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$110K - $130K *

Elevate your career by leading automation design and implementation in manufacturing. Collaborate with cross-functional teams to enhance operational excellence and drive strategic initiatives, ensurin...

Yesterday

  •   8 - 10 years exp.  •   Business Services

$100K - $120K *

Deliver instrumentation and controls engineering services, ensuring compliance with specifications, budgets, and timelines. Guide projects, support teams, and drive technical excellence to meet client...

3 weeks ago

  •   5 - 7 years exp.  •   Staffing

$149K - $239K *

Join us in driving compliance excellence by managing quality systems and regulatory processes. You'll lead initiatives, assess risks, and promote continuous improvement across global teams to ensure o...

2 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$190K - $220K *

Drive your career by leading a global trade compliance program, ensuring adherence to international regulations while enhancing governance and operational efficiency across a complex business landscap...

United StatesRemote

3 weeks ago

  •   11 - 15 years exp.  •   Business Services

$95K - $115K *

Shape the future of biologics manufacturing by leading process development and optimization for downstream purification. Drive technology transfer and scale-up initiatives while collaborating across t...

Reposted 1 week 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.