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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$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...

Yesterday

  •   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...

6 days 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

$158K - $190K *

Drive regulatory business development by leading assessments, formulating strategies, and managing cross-functional teams to identify and mitigate risks in new opportunities, ensuring alignment with c...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$160K - $190K *

Elevate your career by leading regulatory assessments and strategies to drive business development initiatives. Collaborate with cross-functional teams to identify opportunities and mitigate risks in...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Champion regulatory excellence by leading submissions and ensuring compliance with FDA guidelines while collaborating with cross-functional teams to support innovative biopharmaceutical products...

Reposted 3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$85K - $115K *

Champion the global pharmacovigilance function by overseeing safety case processing, ensuring compliance, and collaborating with cross-functional teams to enhance operational efficiency and data integ...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$135K - $165K *

Oversee the GVP and GCP compliance program, ensuring regulatory adherence and quality management across pharmacovigilance and clinical studies while collaborating with global QA teams to drive continu...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$135K - $165K *

Help us enhance our GVP and GCP compliance program, ensuring regulatory adherence and quality oversight across pharmacovigilance and clinical studies while collaborating with global QA teams to drive...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Unlock the potential of biomanufacturing by leading CQV activities, ensuring compliance and quality in equipment and systems. Collaborate across teams to drive validation efforts and support regulator...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $138K *

Lead the charge in clinical trial monitoring, ensuring compliance and quality. Collaborate with teams to enhance data integrity and site performance while providing training and support to maintain hi...

RemoteRemote

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$142K - $224K *

Join a dynamic team to lead global CMC regulatory strategies for biologics and ADCs. Drive regulatory milestones through product development and ensure compliance with international guidelines while c...

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$142K - $224K *

Lead and execute global Regulatory CMC strategies for synthetic moieties in biologics, ensuring compliance through all phases of drug development. Collaborate cross-functionally to meet regulatory mil...

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$210K - $334K *

Join a dynamic team as a strategic legal partner, providing expert counsel on regulatory, quality, and compliance matters for medical devices globally, while managing complex legal projects and advisi...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$110K - $130K *

Transform biopharmaceutical manufacturing processes by leading technical initiatives, ensuring compliance, and driving continuous improvements. Collaborate with cross-functional teams to enhance produ...

2 days ago

  •   Less than 5 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.