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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$100K - $130K *

Join a dynamic team to lead the contracts lifecycle management process, ensuring compliance and minimizing risks while managing complex agreements in the high-tech industry. Collaborate with stakehold...

Brampton, ONIn-Person

5 days ago

  •   8 - 10 years exp.  •   Aerospace & Defense

$88K - $220K *

Lead the development of analytic datasets and conduct longitudinal analyses for observational studies in virology. Collaborate with epidemiologists and manage complex analyses while ensuring adherence...

5 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$125K - $150K *

Lead the charge in regulatory affairs by guiding a team to develop and execute strategies for new products, ensuring compliance and supporting lifecycle management while collaborating with cross-funct...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$120K - $160K *

Transform your career by leading strategic planning efforts, collaborating across military and civilian domains to produce timely, high-quality decision-making materials that support operational succe...

Reposted 3 days ago

  •   5 - 7 years exp.  •   Information Technology

$89K - $91K *

Engage with clients and enhance product positioning by providing technical support, training, and marketing resources for GCMS operations. Collaborate with sales and marketing teams to address custome...

Reposted 2 weeks ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$200K - $275K *

Transform global GCP compliance for clinical trials, leading audits and vendor management while ensuring quality systems meet regulatory standards. Drive continuous improvement and inspection readines...

Yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$74K - $97K *

Unlock potential by designing and implementing risk-based quality assurance programs. Collaborate with multi-functional teams to ensure contractor compliance and enhance processes, while providing tec...

4 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$95K - $115K *

Lead quality initiatives in a high-volume electronics manufacturing environment, ensuring compliance and driving continuous improvement. Collaborate with cross-functional teams to enhance product qual...

Today

  •   5 - 7 years exp.  •   Consumer Technology

$95K - $115K *

Champion quality excellence in a dynamic manufacturing environment. Lead initiatives to enhance product quality, customer satisfaction, and operational performance while collaborating with cross-funct...

Yesterday

  •   5 - 7 years exp.  •   Consumer Technology

$173K - $272K *

Drive excellence in biologics commercialization by leading process development, scale-up, and validation activities. Collaborate cross-functionally to ensure timely and compliant product launches whil...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$114K - $165K *

Join a team that's dedicated to ensuring the highest quality and safety standards for medical devices post-commercialization. Drive compliance, process improvements, and risk management while collabor...

2 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$106K - $167K *

Champion safety excellence by leading high-risk work initiatives and machinery safety programs. Collaborate with cross-functional teams to implement risk-based solutions, ensuring compliance and drivi...

4 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$106K - $167K *

Lead safety initiatives for high-risk work and machinery across multiple sites, ensuring compliance and risk mitigation. Collaborate with cross-functional teams to enhance safety protocols and drive c...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$72K - $130K *

Lead the charge in compliance monitoring and testing to ensure adherence to regulations and internal standards. Evaluate controls, identify risks, and report findings to management, driving improvemen...

Lincoln, NERemote

3 days ago

  •   Less than 5 years exp.  •   Healthcare

$95K - $115K *

Accelerate progress at our pharmaceutical manufacturing site by driving measurable improvements through the Practical Process Improvement (PPI) Business System. Engage in hands-on problem solving, pro...

2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$206K - $230K *

Elevate quality assurance standards by leading cross-functional initiatives, managing document control, and ensuring compliance in a dynamic environment. Drive inspection readiness and mentor teams to...

Yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$90K - $120K *

Transform regulatory compliance by managing medical device labeling and documentation across multiple regions, ensuring accuracy and audit readiness while collaborating with cross-functional teams to...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$108K - $130K *

Lead the charge in enhancing supplier quality management across multiple sites. Ensure compliance with regulatory standards, drive continuous improvement initiatives, and serve as the key liaison for...

Reposted 4 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$89K - $148K *

Lead supplier quality initiatives by applying rigorous standards, managing performance metrics, and fostering collaboration to ensure compliance and continuous improvement across diverse programs with...

3 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$89K - $148K *

Join a team that's dedicated to enhancing supplier quality through strategic planning, performance monitoring, and risk management. Collaborate across programs to ensure robust supplier processes and...

3 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$89K - $148K *

Advance supplier quality initiatives by managing performance, implementing evaluation systems, and ensuring compliance with quality standards across programs. Collaborate with teams to drive continuou...

3 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$270K - $335K *

Champion Brex's Regulatory Affairs, managing engagements with federal and state regulators. Guide strategy and compliance across teams, ensuring timely responses and proactive risk management in a com...

4 weeks ago

  •   8 - 10 years exp.  •   Finance & Insurance

$270K - $335K *

Lead the charge in managing regulatory affairs and ensuring compliance, fostering relationships with federal & state regulators. Oversee engagement lifecycle & deliver timely responses while providing...

1 month ago

  •   8 - 10 years exp.  •   Finance & Insurance

$73K - $132K *

Lead the procurement cycle, negotiate contracts, and collaborate across functions to ensure successful management of federal subcontracts while driving innovation, compliance, and cost-effective solut...

United StatesRemote

Reposted 2 days ago

  •   Less than 5 years exp.  •   Technical Services

$73K - $132K *

Lead the charge in subcontract management and negotiations to drive effective procurement for government programs. Collaborate with cross-functional teams while navigating complex challenges and deliv...

Reposted 2 weeks ago

  •   Less than 5 years exp.  •   Technical Services

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.