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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$113K - $145K *

Join a dynamic team to enhance manufacturing processes through cross-functional collaboration, data analysis, and continuous improvement initiatives, ensuring quality and efficiency in production oper...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$164K - $205K *

Champion GxP compliance through internal and external audits, vendor management, and quality agreements. Collaborate cross-functionally to enhance processes, ensure regulatory readiness, and drive sup...

2 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$130K - $150K *

Unlock potential by managing corporate legal operations, supporting governance, and enhancing contract management processes in a fast-paced biotech environment. Collaborate with leadership to drive sc...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$63K - $105K *

Elevate procurement strategies by acting as a key liaison between sourcing teams and manufacturing sites, driving cost savings and vendor relationships while ensuring alignment with broader organizati...

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Deliver expert advisory services to life sciences firms, optimizing government pricing strategies and ensuring compliance. Collaborate with clients to support project execution and drive impactful out...

Philadelphia, PARemote

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Drive strategic advisory services supporting life sciences clients in government pricing, compliance, and contracting; facilitating product launches while enhancing pricing frameworks for optimal enga...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Transform data into insights as you drive process excellence in cell therapy manufacturing. Collaborate across teams to enhance quality and efficiency through statistical analysis and automation, ensu...

2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$130K - $145K *

Unlock your potential by ensuring product compliance and leading improvement projects. Collaborate with cross-functional teams to maintain quality standards and support regulatory audits while driving...

1 week ago

  •   8 - 10 years exp.  •   Healthcare

$110K - $130K *

Drive excellence in satellite procurement programs by providing expert product assurance engineering support throughout design, assembly, and launch phases, ensuring quality standards and effective re...

4 days ago

  •   5 - 7 years exp.  •   Transportation

$67K - $110K *

Join our team to enhance QC microbiology operations, leading initiatives to improve laboratory testing methods and compliance while serving as a key technical resource and driving operational excellen...

Reposted 2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Join a dynamic team to elevate supplier quality standards, lead initiatives, and drive continuous improvement. Collaborate across functions to enhance performance metrics and ensure alignment with glo...

Reposted 6 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$90K - $110K *

Transform quality and compliance processes by leading ISO and AS9100D initiatives. Ensure corporate certification integrity while fostering a culture of compliance and continuous improvement in a dyna...

3 weeks ago

  •   5 - 7 years exp.  •   Staffing

$134K - $205K *

Lead the charge in optimizing nuclear power plants by providing expert evaluations and consulting on power uprates, utilizing advanced mechanical engineering principles to meet growing energy demands...

4 weeks ago

  •   11 - 15 years exp.  •   Technical Services

$80K - $95K *

Champion validation excellence by supporting critical qualification activities for laboratory instruments and GMP equipment. Collaborate with cross-functional teams to ensure compliance and data integ...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Lead the design and integration of advanced GN&C systems for the ISS, ensuring real-time performance analysis and anomaly resolution. Collaborate with a dynamic team to support mission operations and...

2 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$93K - $232K *

Lead the execution of multi-regional clinical trials, ensuring timely delivery, quality, and compliance. Collaborate with cross-functional teams and sponsors to drive project success and foster strong...

Reposted 6 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$93K - $232K *

Drive the execution of multi-regional clinical trials, ensuring timely delivery, quality, and compliance. Collaborate with cross-functional teams and sponsors to manage project scope, budgets, and ris...

Reposted 6 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$93K - $232K *

Shape the future of clinical research by leading multi-regional trials, ensuring timely delivery and compliance. Collaborate with cross-functional teams and sponsors to drive project success and mento...

Reposted 6 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$99K - $129K *

Unlock potential by ensuring supplier quality excellence in a dynamic environment. Collaborate closely with suppliers and cross-functional teams to mitigate risks and drive continuous improvement in h...

Reposted today

  •   5 - 7 years exp.  •   Healthcare

$74K - $100K *

Support the development of innovative analytical tools and ensure quality attributes for large molecule therapies, collaborating with cross-functional teams in a GMP environment to conduct testing and...

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$117K - $176K *

Drive excellence in subcontract management by sourcing, negotiating, and overseeing supplier contracts. Collaborate with cross-functional teams to ensure compliance and performance, while identifying...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$79K - $120K *

Elevate your career by joining our Manufacturing Science and Technology team, where you'll lead process validation and cleaning initiatives for innovative biotherapeutics, ensuring compliance and exce...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$137K - $235K *

Lead the charge in preclinical integration and transition management, coordinating cross-functional teams to ensure successful asset transitions and operational readiness. Drive strategic initiatives...

2 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$64K - $128K *

Elevate your career by driving compliance initiatives and supporting regulatory standards. Collaborate with a high-performing team to manage compliance processes, audits, and training while enhancing...

3 weeks ago

  •   Less than 5 years exp.  •   Finance & Insurance

$64K - $128K *

Contribute to the compliance initiatives while managing regulatory reviews, ensuring adherence to multiple securities laws, and supporting audits for investment advisers and broker-dealers...

3 weeks ago

  •   Less than 5 years exp.  •   Finance & Insurance

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.