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.

Remote
caret down
Compensation
caret down
Position Level
caret down
Time Posted
caret down
Industries
caret down
Locations
caret down
More
1
caret down

$83K - $102K *

Lead the charge in managing CDMO vendor relationships while ensuring seamless logistics, performance tracking, and communication across drug substance programs. Drive operational excellence and elevat...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Contribute to global quality excellence by overseeing QA/QC processes, ensuring compliance, and driving harmonization across sites while collaborating with cross-functional teams to optimize performan...

Reposted 3 weeks ago

  •   8 - 10 years exp.  •   Business Services

$136K - $184K *

Empower regulatory excellence by leading strategic compliance operations, enhancing member experience and operational efficiency while ensuring adherence to evolving CMS and NCQA standards across mult...

Reposted today

  •   5 - 7 years exp.  •   Healthcare

$136K - $184K *

Oversee a dynamic Clinical Regulatory Operations team, driving compliance and operational excellence across health services while partnering with stakeholders to enhance member care. Lead innovative s...

Reposted today

  •   5 - 7 years exp.  •   Healthcare

$136K - $184K *

Lead the charge in regulatory excellence by guiding a clinical operations team to ensure compliance, advance operational efficiency, and enhance member experience through strategic partnerships and in...

Reposted today

  •   5 - 7 years exp.  •   Healthcare

$135K - $216K *

Drive global regulatory strategies by aligning and executing advertising and promotion initiatives, while collaborating across business units and regions to enhance efficiency and compliance in a dyna...

Reposted 3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$88K - $105K *

Drive compliance projects by leveraging 10+ years of regulatory expertise. Manage client relationships and deliver high-quality reports while ensuring adherence to environmental regulations and local...

4 days ago

  •   8 - 10 years exp.  •   Technical Services

$141K - $262K *

Empower early clinical development by embedding a proactive quality culture. Serve as a GCP advisor, resolving compliance challenges and enhancing study integrity through strategic partnerships and ri...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Innovate within a dynamic engineering environment, applying standard techniques to enhance product quality and compliance. Collaborate on projects, manage risks, and drive continuous improvement in pr...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$222K - $303K *

Champion regulatory excellence by leading CMC strategies for global drug approvals. Collaborate across teams to navigate complex regulations, ensuring compliance and successful product lifecycle manag...

New Jersey, USRemote

Reposted today

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$222K - $303K *

Drive regulatory leadership for early-stage drug development with cross-functional collaboration, supporting strategic business decisions and ensuring strong regulatory alignment throughout product li...

New Jersey, USRemote

Reposted today

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$100K - $140K *

Join a team that's advancing pharmaceutical technology transfer and quality control through analytical excellence, method validation, and leadership in a dynamic, compliance-focused environment. Drive...

4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$125K - $147K *

Optimize product safety engineering by applying expertise in IEC 62368-1 and IEC 61010-1. Collaborate with teams, mentor junior staff, and manage multiple projects while ensuring compliance with U.S...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$255K - $424K *

Drive strategic technology initiatives across Regulatory Affairs, Medical Affairs, and Clinical Data. Lead a team to enhance platform capabilities, ensuring alignment with business objectives and comp...

2 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$255K - $424K *

Join a team that's shaping the future of regulatory, medical, and clinical data technology. Lead strategic initiatives, manage a talented team, and ensure compliance while driving innovation across pl...

2 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$89K - $143K *

Develop and execute strategies for managing reference materials and assay controls, ensuring compliance with cGMP standards. Collaborate with cross-functional teams to support clinical and commercial...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$100K - $125K *

Lead innovative preclinical studies in medical device biocompatibility, overseeing protocol development, execution, and reporting while ensuring compliance with industry standards and regulations. Eng...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$76K - $142K *

Analyze bioanalytical testing processes to ensure compliance with regulatory standards and internal quality metrics. Collaborate with cross-functional teams to enhance product development and maintain...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$92K - $110K *

Optimize global regulatory compliance programs related to hazardous materials, waste management, and packaging. Lead governance frameworks and strategies, collaborating with cross-functional teams to...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$90K - $110K *

Support pharmaceutical clients by enhancing aseptic operations and compliance. Leverage expertise in cGMP regulations to identify performance gaps and implement tailored strategies, driving measurable...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$101K - $169K *

Shape the future of product quality by providing expert guidance in quality engineering for New Product Introduction and Life Cycle Management, ensuring compliance with regulatory standards and drivin...

3 weeks ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$89K - $166K *

Elevate quality standards by partnering with manufacturing teams to ensure compliance and integrity throughout production. Your expertise will drive continuous improvement and enhance patient safety i...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$130K *

Partner with us to innovate and transform Quality & Regulatory operations through technology and data analytics. Drive automation, improve efficiency, and foster effective digital solutions that enhan...

United StatesRemote

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$213K - $286K *

Drive regulatory CMC strategy and execution for biologics programs, ensuring high-quality submissions and compliance with global standards. Collaborate across teams to guide development strategy and i...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Transform the client onboarding experience as a Senior AR Specialist. Engage directly with new clients, optimize workflows, and refine our AI tools through real-world testing, ensuring a seamless tran...

Reposted 4 weeks ago

  •   5 - 7 years exp.  •   Healthcare

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.