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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$136K - $184K *

Join a team that champions health care transformation by leading clinical regulatory operations to ensure compliance, enhance quality, and improve member experience across diverse clinical settings th...

Reposted today

  •   5 - 7 years exp.  •   Healthcare

$136K - $184K *

Lead a clinical regulatory operations team, ensuring compliance while enhancing operational efficiency and member experience. Partner with stakeholders to streamline processes, implement compliance fr...

Reposted today

  •   5 - 7 years exp.  •   Healthcare

$136K - $184K *

Drive regulatory excellence by leading clinical operations teams to ensure compliance with CMS, NCQA, and privacy regulations, while enhancing member experience through operational improvements and st...

Reposted today

  •   5 - 7 years exp.  •   Healthcare

$136K - $184K *

Lead a dedicated clinical regulatory operations team to enhance compliance and operational excellence. Partner with business leaders to optimize health services while ensuring adherence to regulatory...

Reposted today

  •   5 - 7 years exp.  •   Healthcare

$115K - $172K *

Drive compliance and sustainability initiatives by developing and implementing environmental programs that align with regulatory standards and company goals, ensuring a safe and eco-friendly workplace...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$155K - $204K *

Elevate our regulatory strategy by providing expert guidance, ensuring compliance, and managing cross-functional partnerships. Lead initiatives that support sustainable growth and adapt to evolving re...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Food & Beverages

$76K - $95K *

Join a team that's committed to ensuring GMP compliance and quality oversight for the commissioning and qualification of a new biologics production facility, driving excellence in the pharmaceutical i...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$82K - $124K *

Transform your career by guiding clinical research teams in quality assurance and regulatory compliance. Leverage your expertise to ensure adherence to federal regulations and enhance the integrity of...

3 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$68K - $133K *

Drive the procurement and validation of Measurement and Test Equipment, ensuring compliance with industry standards. Collaborate with teams to analyze data, maintain documentation, and provide trainin...

4 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Join a team that's dedicated to enhancing medical device performance and compliance. Lead design verification projects, collaborate with cross-functional teams, and ensure product reliability and regu...

Yesterday

  •   8 - 10 years exp.  •   Healthcare

$100K - $120K *

Elevate compliance standards by leading regulatory affairs in a laboratory setting. Ensure quality assurance, manage audits, and foster a culture of safety and accountability while collaborating acros...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Champion robust validation processes for ERP systems, ensuring compliance with regulatory standards and seamless cross-functional collaboration. Drive operational excellence through effective risk-bas...

Reposted 3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Elevate your career by overseeing clinical monitoring and site management. Collaborate with teams to ensure compliance with protocols and regulations, while fostering relationships with investigationa...

North Carolina, USRemote

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Manage clinical trial operations, ensuring compliance and performance across protocols. Oversee submissions, budgets, and team coordination while collaborating with internal and external stakeholders...

Quebec, CARemote

5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Join a team that's shaping the future of biopharmaceutical manufacturing by leading the design and improvement of critical electrical systems, ensuring reliability and compliance while driving sustain...

3 days ago

  •   5 - 7 years exp.  •   Business Services

$346K - $454K *

Inspire global product registration strategies while leading cross-functional teams to enhance patient access to diagnostic solutions. Collaborate with stakeholders to ensure compliance and drive inno...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$346K - $454K *

Elevate global regulatory strategies to ensure timely product access and compliance. Collaborate with diverse teams and leaders to embed innovative practices, while guiding a high-performing regulator...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$346K - $454K *

Empower global access to innovative diagnostic solutions by leading a high-performing regulatory team. Drive strategy, compliance, and collaborative partnerships with regulatory bodies, ensuring timel...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$346K - $454K *

Drive global regulatory strategy and empower teams to ensure timely product registrations, enhancing access to innovative diagnostic solutions. Collaborate with leadership to shape impactful strategie...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$346K - $454K *

Transform your career by leading global regulatory affairs and driving innovative solutions in diagnostics. Empower teams, develop registration strategies, and enhance patient access while collaborati...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$90K - $110K *

Join as a key player in supporting GMP Manufacturing Operations, driving product/process improvements, coaching associates, and ensuring compliance in a dynamic biopharmaceutical environment while enh...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$77K - $129K *

Lead the charge in quality engineering for new product development, collaborating with cross-functional teams to ensure safety, effectiveness, and manufacturability of mechanical designs while driving...

Yesterday

  •   Less than 5 years exp.  •   Healthcare

$89K - $148K *

Drive quality excellence in new product introductions, ensuring compliance and efficiency through risk management, validation, and cross-functional collaboration in a regulated environment...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$89K - $148K *

Elevate product and process quality by collaborating with cross-functional teams to ensure compliance, resolve issues, and drive continuous improvement initiatives in manufacturing operations...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$164K - $282K *

Lead the charge in shaping global regulatory strategies for innovative orthopaedic products. Drive excellence in product launches and portfolio management while mentoring a talented team to ensure com...

Reposted yesterday

  •   8 - 10 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.