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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$142K - $224K *

Lead the charge in complex device development programs, orchestrating cross-functional teams to deliver innovative combination products from concept to launch while ensuring regulatory compliance and...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Join a dynamic team to oversee Quality Assurance for Drug Substance Manufacturing, ensuring compliance and operational excellence from development through commercial release while driving process impr...

2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$147K - $241K *

Unlock your potential by leading quality compliance initiatives in CMC Regulatory Affairs. Collaborate with cross-functional teams to drive strategic assessments and enhance organizational alignment...

3 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $90K *

Transform our deviation management process in GMP sterile manufacturing. Lead investigations, root cause analysis, and drive compliance with FDA standards. Be the key point of contact for deviations...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$88K - $134K *

Lead the charge in quality assurance by managing complex projects, mentoring team members, and driving improvements in product performance. Utilize your expertise in protein-based immunoassays to ensu...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$85K - $100K *

Unlock your potential in regulatory affairs, supporting drug, biologic, and device projects. Collaborate with teams, prepare key documents, and engage with health authorities to ensure compliance and...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Optimize regulatory processes by ensuring compliance with FDA submissions and guidelines. Collaborate cross-functionally to review and approve applications, enhancing the quality and accuracy of submi...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Join a team championing Quality Assurance initiatives, enhancing operational efficiency, and fostering a culture of excellence. Collaborate across functions to address quality gaps, ensuring complianc...

Reposted 4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$62K - $128K *

Elevate quality assurance standards by validating laboratory and analytical equipment in a cutting-edge biologics facility, ensuring compliance with regulatory requirements and supporting manufacturin...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$87K - $168K *

Transform the quality assurance landscape by leading the Radiation Protection Program's quality systems. Drive compliance, enhance processes, and ensure safety standards while collaborating with diver...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$110K - $130K *

Join a dynamic team as a Senior ISO 9001 Quality Management Specialist, providing expertise in quality management systems and continuous improvement for federal programs. Drive operational excellence...

1 week ago

  •   8 - 10 years exp.  •   Business Services

$275K - $375K *

Lead global regulatory strategy and execution for clinical development, ensuring alignment across teams. Provide strategic guidance to senior leadership and manage high-quality regulatory submissions...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$172K - $275K *

Accelerate innovation by establishing and executing regulatory digital strategies that enhance operational excellence and enable data-driven decisions across business units and regions while leading h...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Healthcare

$160K - $190K *

Transform regulatory affairs by leading strategic initiatives in advertising, promotion, and labelling for global products. Drive compliance and innovation while collaborating with cross-functional te...

New Jersey, USRemote

2 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$145K - $160K *

Join a team that's dedicated to optimizing production equipment and automation processes in the pharmaceutical industry. Lead cross-functional efforts to enhance quality, efficiency, and compliance wh...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$145K - $165K *

Join a team that's advancing oncology products by supporting regulatory submissions and strategic planning. Collaborate cross-functionally to ensure compliance and quality in a fast-paced environment...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Drive innovative laboratory projects by providing expert project management and technical leadership. Oversee design, assessment, and field-testing solutions while ensuring successful delivery across...

Edmonton, ABIn-Person

3 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$86K - $130K *

Join a team that's dedicated to advancing animal health by leading regulatory submissions and strategies for product approvals. Use your expertise to navigate compliance and engage with authorities fo...

Mississauga, ONIn-Person

Reposted 3 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Drive excellence in quality management systems by coordinating essential quality activities, enhancing processes, and ensuring compliance across teams to support patient-centered care and operational...

4 days ago

  •   Less than 5 years exp.  •   Healthcare

$190K - $300K *

Lead the charge in global regulatory strategy development for innovative cardiovascular programs, ensuring efficient approval processes and strategic oversight to accelerate drug advancements through...

Reposted 5 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$190K - $300K *

Unlock potential by leading global regulatory strategies in cardiovascular and metabolic programs. Collaborate with cross-functional teams to ensure timely drug approvals while managing complex projec...

Reposted 5 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$190K - $300K *

Unlock your potential as a strategic leader in global regulatory affairs, driving innovative cardiovascular solutions and ensuring rapid approval processes while managing complex development programs...

Reposted 5 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$190K - $300K *

Redefine global regulatory strategy by leading complex cardiovascular programs, driving optimal results with minimal oversight while engaging with global regulatory agencies for timely approvals and c...

Reposted 5 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Drive product quality and safety through global monitoring and evaluation of feedback, ensuring compliance with regulatory standards while fostering strong customer relationships and providing clinica...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$102K - $133K *

Drive excellence in document control by managing processes, ensuring compliance, and enhancing accessibility of critical documentation. Collaborate cross-functionally to support quality management and...

3 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

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.