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.
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.
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.
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.
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.
Engineering Senior Specialist, Global Engineering Solutions
$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
$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
$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
$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
$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
Senior Product Safety Engineer, Renewable Energy
$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
$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
Senior Specialist, Procurement
$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
Senior Specialist, Procurement
$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
Senior Regulatory Affairs Program Lead (Wound Closure & Healing) - MedTech Surgery
$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
Associate Principal Scientist, Regulatory CMC, Synthetic Moities of ADCs & Bioconjugates
$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
$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
Director, Regulatory Affairs Business Development
$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
Director, Regulatory Affairs Business Development
$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
Director, Regulatory Affairs Business Development
$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
$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
Sr. Pharmacovigilance Ops Specialist - Oncology 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
$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
$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
$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
Senior Clinical Research Associate - Medical Device
$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...
1 week ago
Associate Principal Scientist, Regulatory CMC, Synthetic Moities of ADCs & Bioconjugates
$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
Associate Principal Scientist, Regulatory CMC, Synthetic Moities of ADCs & Bioconjugates
$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
Senior Director, Regulatory & Quality Counsel, Global
$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
$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
What does a senior regulatory affairs specialist do?
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?
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?
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?
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?
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.