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 - $130K *

Manage and enhance quality standards across diverse projects, ensuring compliance with specifications and regulations. Collaborate with teams to drive quality initiatives and mentor staff, contributin...

1 week ago

  •   8 - 10 years exp.  •   Real Estate & Construction

$110K - $130K *

Lead regulatory affairs for impactful lung research, coordinating clinical trials, budgets, and IRB approvals. Collaborate with principal investigators and oversee research coordinators to ensure comp...

1 week ago

  •   Less than 5 years exp.  •   Education, Government & Non-Profit

$93K - $126K *

Lead the quality management initiatives across scientific functions, ensuring compliance with GRP, GLP, and GCP standards while fostering collaboration and a culture of continuous improvement to drive...

4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$75K - $90K *

Join a team that's dedicated to ensuring compliance in food labeling and regulations. Lead daily operations in a collaborative environment, supporting product development while navigating USDA guideli...

2 weeks ago

  •   Less than 5 years exp.  •   Food & Beverages

$117K - $218K *

Unlock innovative data solutions by driving AI and analytics in product development. Collaborate with cross-functional teams to prototype and scale transformative technologies that enhance decision-ma...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$91K - $132K *

Shape supplier quality initiatives by analyzing data, collaborating with teams, and ensuring compliance with industry standards. Leverage your expertise to enhance material quality and drive continuou...

1 week ago

  •   Less than 5 years exp.  •   Food & Beverages

$100K - $120K *

Lead the charge in regulatory affairs by managing a team, overseeing study start-up activities, and ensuring compliance across multiple studies and regions. Drive quality and efficiency while mentorin...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Shape regulatory strategies and oversee study start-up activities across multiple regions. Lead a team of specialists, ensuring compliance and timely execution of studies while managing risks and fost...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Engage in quality assurance by executing audits and inspections, ensuring compliance with regulatory standards, and driving continuous improvement initiatives across cross-functional teams to enhance...

1 week ago

  •   8 - 10 years exp.  •   Staffing

$110K - $130K *

Lead US regulatory safety and efficacy strategies in global projects, ensuring compliance and timely product approvals. Collaborate with project teams and stakeholders, guiding submissions and maintai...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$90K - $110K *

Manage contract reviews and negotiations, ensuring compliance and risk mitigation. Collaborate with cross-functional teams to streamline processes and enhance contract performance while providing expe...

Ontario, CARemote

4 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$154K - $242K *

Take ownership of regulatory compliance for promotional materials in the pharmaceutical sector. Leverage your expertise to guide cross-functional teams, mentor staff, and ensure adherence to FDA regul...

Massachusetts, USRemote

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$265K - $300K *

Transform legal strategy for market access initiatives, providing expert counsel and contract support. Collaborate with cross-functional teams to navigate complex regulations and ensure compliance, dr...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Drive process improvements and technical excellence in ceramic manufacturing. Collaborate with cross-functional teams to resolve complex issues, mentor junior engineers, and ensure sustained gains in...

Yesterday

  •   5 - 7 years exp.  •   Aerospace & Defense

$95K - $116K *

Empower product excellence by ensuring compliance with regulatory standards. Leverage your expertise to influence industry norms and advocate for best practices. Collaborate across functions, driving...

3 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$100K - $120K *

Manage complex subcontracting activities to ensure successful project execution, focusing on commercial leadership, risk management, and stakeholder collaboration. Drive strategies that align with pro...

2 weeks ago

  •   5 - 7 years exp.  •   Real Estate & Construction

$100K - $120K *

Engineer your career by leading subcontracting processes for major industrial projects. Drive commercial success through strategic sourcing, negotiations, and stakeholder engagement while mentoring te...

Edmonton, ABIn-Person

3 weeks ago

  •   8 - 10 years exp.  •   Real Estate & Construction

$120K - $195K *

Lead the charge in operational excellence by managing a diverse clinical team across regions, ensuring timely and quality clinical deliverables while driving strategic initiatives and fostering talent...

RemoteRemote

3 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$187K - $253K *

Shape the future of regulatory technology by leading strategic initiatives that enhance compliance, efficiency, and insight-driven operations across Regulatory Affairs and Medical Writing, ensuring se...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$154K - $231K *

Transform safety management by leading medical device vigilance and pharmacovigilance activities. Ensure compliance with global regulations while overseeing adverse event reporting and risk assessment...

Today

  •   5 - 7 years exp.  •   Healthcare

$155K - $175K *

Lead the charge in client partnerships while driving strategic growth and team development. Utilize your expertise to deliver impactful insights and solutions in a fast-paced, evolving environment, en...

RemoteRemote

Reposted 1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$130K - $155K *

Take ownership of safety analysis deliverables, ensuring high quality and timely execution while leading cross-disciplinary collaboration to support the Mark 1 reactor's licensing and design phases...

Reposted 4 weeks ago

  •   Less than 5 years exp.  •   Energy & Utilities

$67K - $110K *

Unlock your potential as a Quality Assurance Specialist, ensuring compliance and excellence in manufacturing processes. Collaborate cross-functionally to drive quality initiatives and mentor junior st...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$92K - $150K *

Elevate quality assurance standards by supporting bulk batch reviews, ensuring compliance with QA policies, and collaborating across departments to resolve issues while mentoring junior staff and driv...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$125K - $150K *

Innovate global CMC regulatory strategies and submissions for biological products. Ensure high-quality compliance with US and Canadian regulations, while collaborating cross-functionally to manage lif...

RemoteRemote

Reposted 3 weeks ago

  •   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.