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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$110K - $112K *

Collaborate with cross-functional teams to drive product development for in vitro diagnostics, ensuring compliance with quality standards and timely project delivery while managing multiple initiative...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$120K - $145K *

Join a team that's dedicated to producing high-quality clinical supplies. Lead manufacturing operations, collaborate on formulation development, and ensure compliance with cGMP standards while driving...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$88K - $132K *

Join our team as a Senior Procurement Specialist, where you'll manage procurement processes, negotiate contracts, and ensure compliance with corporate policies. Collaborate with internal customers to...

Today

  •   5 - 7 years exp.  •   Enterprise Technology

$173K - $204K *

Join a team that's dedicated to enhancing clinical quality through effective GCP oversight and audits, supporting clinical studies and ensuring compliance while mentoring the next generation of QA pro...

Reposted 1 month ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$90K - $112K *

Take ownership of quality assurance processes, ensuring compliance with industry standards and supplier activities. Collaborate with engineering and vendors to enhance product quality and drive contin...

Newington, NHIn-Person

2 weeks ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$137K - $215K *

Champion global compliance and audit readiness in Regulatory Affairs. Lead cross-functional collaboration, manage GCP audits, and drive continuous improvement initiatives to enhance processes and ensu...

4 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Champion the clinical execution of complex studies, leading scientific oversight and medical monitoring while collaborating with cross-functional teams to ensure compliance and deliver impactful resul...

Ontario, CARemote

5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$140K - $170K *

Deliver expert validation leadership by managing complex projects, ensuring compliance with industry standards, and collaborating across functions to maintain the integrity of manufacturing processes...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$228K *

Join a dynamic team to lead clinical trials, develop strategies, and ensure high-quality deliverables in oncology drug development while collaborating with cross-functional teams and mentoring junior...

1 week ago

  •   8 - 10 years exp.  •   Staffing

$79K - $87K *

Drive your career by ensuring the highest quality standards in manufacturing processes, managing customer complaints, regulatory compliance, and quality system audits. Collaborate across teams to enha...

3 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$95K - $115K *

Join a team that's dedicated to designing and optimizing mechanical systems. Lead initiatives in DFM, product redesign, and FEA while collaborating cross-functionally to ensure project success from co...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$160K - $180K *

Join our team to lead Quality Assurance efforts, ensuring compliance with regulatory standards while supporting clinical and manufacturing operations. Drive quality initiatives and mentor a dedicated...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$130K - $232K *

Join a team that's driving innovation in AI and Cyber solutions. Collaborate with sales executives to develop strategies, enhance client engagement, and lead market initiatives while mentoring staff t...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$130K - $232K *

Engage with Energy & Industrial Sales teams to drive AI & Cyber project success. Develop market strategies, refine service proposals, and present solutions at key events while mentoring staff and ensu...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$130K - $232K *

Unlock potential by collaborating with sales teams to drive AI & Cyber projects, develop market strategies, and enhance client solutions. Leverage technical expertise to mentor staff and present innov...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$130K - $232K *

Drive strategic initiatives in AI & Cyber, collaborating with sales teams to enhance market presence and achieve sales goals while mentoring staff and presenting innovative solutions to clients...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$130K - $232K *

Drive growth by collaborating with sales teams to close AI & Cyber projects, develop market strategies, and enhance client solutions. Leverage technical expertise to mentor staff and present innovativ...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$130K - $232K *

Join a team that's driving innovation in AI and Cyber solutions. Collaborate with sales executives to develop strategies, mentor staff, and present cutting-edge proposals, all while achieving sales ta...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$100K - $120K *

Accelerate compliance and quality improvement in drug production by leading Quality Assurance initiatives and regulatory oversight, fostering relationships with stakeholders, and implementing effectiv...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$164K - $215K *

Lead the charge in designing and delivering global real-world evidence studies that drive impactful insights, inform stakeholder decisions, and advance scientific understanding in diverse disease area...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$129K - $147K *

Transform the regulatory landscape by leading CMC strategies for biologic, cell, and gene therapy products. Drive compliance, manage submissions, and collaborate with cross-functional teams to ensure...

3 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Join us to enhance post-market surveillance efforts by analyzing data, leading meetings, and ensuring compliance with global regulations. Collaborate with cross-functional teams to support quality ini...

Yesterday

  •   Less than 5 years exp.  •   Healthcare

$80K - $95K *

Empower your career by leading post-market surveillance initiatives, analyzing data, and ensuring compliance with global regulations. Collaborate with cross-functional teams to enhance quality and sup...

Yesterday

  •   Less than 5 years exp.  •   Healthcare

$80K - $95K *

Champion post-market surveillance initiatives by analyzing data, leading meetings, and ensuring compliance with global regulations. Collaborate with cross-functional teams to enhance quality and regul...

Yesterday

  •   Less than 5 years exp.  •   Healthcare

$119K - $165K *

Empower our Supplier Quality team to enhance global performance standards, drive continuous improvement, and foster strategic supplier relationships. Lead initiatives that elevate quality metrics and...

3 days ago

  •   5 - 7 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.