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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$120K - $145K *

Lead the charge in ensuring quality assurance for transport and packaging validation, collaborating with cross-functional teams to uphold compliance and readiness for commercial drug products while ma...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Lead the charge in ensuring quality assurance for transport and packaging validation, collaborating with cross-functional teams to uphold compliance and readiness for commercial launch while managing...

New York, USRemote

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$75K - $90K *

Engage in quality assurance excellence by conducting audits, ensuring compliance, and collaborating with cross-functional teams to uphold regulatory standards and enhance project delivery in a dynamic...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$102K - $133K *

Lead the charge in advancing regulatory compliance and education initiatives, translating complex market developments into clear guidance and training. Collaborate with a dedicated team to enhance ope...

Reposted 4 weeks ago

  •   5 - 7 years exp.  •   Finance & Insurance

$157K - $205K *

Empower organizations by leading innovative data governance strategies that enhance data quality, access, and interoperability. Collaborate with stakeholders to implement best practices and drive a da...

1 week ago

  •   8 - 10 years exp.  •   Business Services

$160K - $259K *

Champion regulatory excellence by leading European strategies for innovative therapies. Drive successful submissions and interactions with health authorities, ensuring compliance and alignment across...

RemoteRemote

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$160K - $259K *

Shape the future of regulatory strategy in Europe by leading cross-functional teams and driving successful submissions for innovative therapies in sleep-wake disorders. Leverage your expertise to navi...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Accelerate progress at ensuring quality and compliance in a dynamic environment. Drive initiatives through document review, audits, and SOP development while mentoring teams to foster a culture of exc...

Today

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$150K - $180K *

Unlock potential by guiding global regulatory strategies for innovative AI/ML healthcare solutions. Collaborate cross-functionally to navigate complex regulations while balancing innovation and patien...

United StatesRemote

Reposted 3 weeks ago

  •   11 - 15 years exp.  •   Healthcare

$90K - $110K *

Elevate project execution by leading capital, construction, and process improvement initiatives from concept to completion while ensuring compliance with safety and quality standards in a collaborativ...

4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$108K - $152K *

Join a team that's dedicated to leading clinical research monitoring efforts, ensuring compliance and quality in trial execution while mentoring a skilled team of CRAs and CRCs to achieve operational...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$117K - $184K *

Elevate your career by collaborating with cross-functional teams to design innovative engineering solutions. Drive operational excellence and continuous improvement in capital projects, ensuring high...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$117K - $184K *

Transform engineering solutions by collaborating with cross-functional teams to design and optimize facilities and processes, ensuring operational excellence and continuous improvement in project deli...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$79K - $127K *

Transform quality assurance in medical device manufacturing by ensuring compliance and safety standards. Collaborate across teams to enhance processes and drive continuous improvement, supporting oper...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$79K - $127K *

Transform quality assurance in medical device manufacturing by ensuring compliance and safety standards. Collaborate across teams to enhance product quality and drive continuous improvement in operati...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Champion the advancement of radiopharmaceutical products by leading analytical method development, process controls, and technology transfers, ensuring compliance and commercial viability from late-st...

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$125K - $150K *

Advance your career by providing strategic legal counsel on environmental, health, and safety regulations. Collaborate with cross-functional teams to ensure compliance and manage risk in manufacturing...

2 weeks ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$100K - $125K *

Elevate your career by providing expert engineering evaluations for renewable energy systems. Conduct compliance testing, develop reports, and support cross-training initiatives while engaging directl...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$85K - $100K *

Join a team that's dedicated to ensuring the validation and quality of biopharmaceutical manufacturing equipment through comprehensive testing, planning, and troubleshooting to maintain compliance and...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$96K - $151K *

Engineer strategic supplier management initiatives to enhance supply chain resilience, drive cost improvements, and support product development. Collaborate across teams to ensure effective sourcing s...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$96K - $151K *

Reimagine supplier management strategies to enhance supply chain resilience, drive cost improvements, and support product development. Collaborate across teams to execute sourcing solutions and optimi...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$109K - $174K *

Shape the future of surgical innovation by leading regulatory strategies for product development and lifecycle management in the Wound Closure and Healing portfolio, ensuring compliance and timely mar...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$142K - $224K *

Optimize regulatory CMC strategies for antibody-drug conjugates and biologics, leading cross-functional teams to meet milestones in both development and post-approval phases while ensuring compliance...

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Champion procurement excellence by leading strategic sourcing initiatives, managing supplier relationships, and driving complex negotiations to optimize cost savings and ensure compliance with best pr...

2 days ago

  •   5 - 7 years exp.  •   Energy & Utilities

$150K - $180K *

Lead regulatory business development initiatives by assessing scientific opportunities, managing cross-functional teams, and formulating strategic recommendations to drive successful partnerships and...

1 week 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.