Senior Regulatory Affairs Specialists are pivotal in ensuring the successful clearance and compliance of products in the global healthcare scene. Their role involves compiling, reviewing, and submitting regulatory documents to government bodies. They ensure that their companies comply with all of the regulations and laws pertaining to their business. Browse through our extensive list of senior regulatory affairs specialist positions in top companies across the country.
Senior Regulatory Affairs Specialists analyze and coordinate the collection of scientific data to be shown in product labeling, investigator brochures, and new drug applications. They also revise product labeling and documentation to ensure compliance with regulatory standards and review the results of laboratory, animal, and human clinical testing trials to determine if they satisfy regulatory requirements.
To become a successful Senior Regulatory Affairs Specialist, strong analytical and communication skills, a keen eye for detail, and a strong background in regulations are required. Mastery of regulatory requirements and dedication to continued learning is crucial for success in this role.
Director/Senior Director, Regulatory Counsel
$172K - $280K *
Lead the charge in regulatory strategy across platforms, guiding compliance in government contracting and life sciences. Shape policies for Consumer and Medical Device sectors, supporting internationa...
3 days ago
$80K - $95K *
Manage senior logistics operations for military aircraft and weapon systems, enhancing supportability and maintainability through strategic analysis, program development, and data evaluation to ensure...
1 week ago
Principal Design Quality Assurance Engineer - Electrophysiology
$106K - $202K *
Lead quality assurance efforts in new product development for medical devices. Collaborate with cross-functional teams to ensure compliance with regulatory standards, drive risk management processes...
5 days ago
$120K - $145K *
Transform aseptic quality assurance by leading a high-performing team, driving compliance through effective monitoring and training, and ensuring best practices in contamination control to deliver top...
5 days ago
Senior Quality Control Inspector
$80K - $95K *
Drive quality assurance initiatives by performing precise inspections and audits on materials, ensuring adherence to specifications and fostering collaboration across teams to uphold high standards in...
3 days ago
Senior Scientist I/II, Process Engineering
$110K - $130K *
Unlock potential by joining our Process Engineering team to develop robust processes for small and large molecule drug production, focusing on crystallization and innovative technologies throughout pr...
2 weeks ago
$110K - $130K *
Lead the charge in designing, building, and testing critical missile structures and systems. Deliver innovative solutions by integrating cross-disciplinary expertise while managing costs and ensuring...
1 week ago
Senior Contracts Administrator
$115K - $130K *
Champion the full lifecycle of contract management, providing strategic guidance, ensuring compliance, and driving successful execution while mentoring junior staff to enhance departmental expertise a...
4 weeks ago
Senior Contracts Administrator
$115K - $130K *
Lead the full contract lifecycle, advising stakeholders and managing risks. Mentor junior team members while driving compliance and delivering high-quality proposals in a fast-paced environment. Join...
4 weeks ago
$95K - $115K *
Lead process development and validation in medical device R&D. Drive complex projects, mentor teammates, and utilize advanced statistics to enhance products from research to implementation. Collaborat...
1 week ago
$100K - $110K *
Optimize the effectiveness of the Quality Management System through cross-functional collaboration and continuous improvement initiatives, ensuring compliance with ISO 13485 and enhancing product qual...
3 days ago
Executive Director, Regulatory Strategy
$268K - $380K *
Lead the charge in regulatory affairs strategy for drug development, overseeing global submissions and gaining agency approvals. Manage a dynamic team, ensuring compliance and high-quality documentati...
2 weeks ago
$106K - $132K *
Champion innovations in precision oncology by supporting patent strategies and intellectual property initiatives. Collaborate with cross-functional teams while developing patent expertise in biotechno...
1 week ago
$136K *
Enhance compliance across therapeutic areas and business functions by leading programs, training, and assessments. Collaborate with teams to interpret regulations and improve compliance strategies, fo...
4 days ago
Senior Process Engineer, Technical Operations - Small Molecule Drug Product (Oral Solid Dose)
$117K - $184K *
Transform the future of oral solid dose manufacturing by leading and optimizing processes in a collaborative environment. Drive technical excellence, technology transfer, and compliance to deliver hig...
Reposted 1 week ago
Associate Director, Regulatory Compliance
$130K - $150K *
Join a team that's redefining regulatory compliance through innovative practices, ensuring adherence to industry standards while managing multiple projects with precision and integrity in a dynamic in...
3 weeks ago
QA Compliance and Regulatory Director
$150K - $180K *
Elevate site Quality Operations by leading compliance initiatives, managing regulatory activities, and ensuring product quality and inspection readiness while inspiring a team focused on excellence an...
2 weeks ago
Senior Risk Analyst, Assurance & Risk Advisory (Internal Audit) - remote
$69K - $110K *
Join our team as a Senior Risk Analyst, executing audits, assessing risks, and enhancing financial processes. This role demands expertise in technical accounting and internal controls, with opportunit...
Yesterday
$88K - $110K *
Elevate your career by driving quality assurance improvements across teams. Engage with key customers and suppliers to enhance delivery performance and compliance within an ISO-based Quality Managemen...
3 days ago
Senior AI PM for Data and Governance
$170K - $200K *
Champion integrated data and analytics platforms, enhancing product efficiency across teams. Own evaluation and governance frameworks ensuring reliable and scalable AI outputs, while facilitating seam...
3 weeks ago
Senior AI PM for Data and Governance
$170K - $200K *
Lead cross-functional integration of data, analytics, evaluation, and governance to enhance healthcare AI products. Drive roadmap ownership, optimize workflows, ensure data quality, and foster collabo...
3 weeks ago
Acquisition Specialist with a TS Clearance
$120K - $180K *
Manage key acquisition efforts by developing and refining procurement documents, ensuring compliance with regulations, and supporting project strategies for security-related initiatives...
2 weeks ago
Quality Engineer - Frederick, MD
$80K - $90K *
Unlock potential by advancing quality management processes and systems. Collaborate with cross-functional teams to ensure compliance with ISO/AS standards and enhance product quality through effective...
3 weeks ago
Senior Manager, Clinical Product Quality - Medical Device/Complaint Handling & Cardiovascular RN
$145K - $205K *
Join a dynamic team as a Senior Manager in Clinical Product Quality, leading investigations, collaborating with cross-functional teams, and driving improvements for product and procedural outcomes in...
3 days ago
Senior Manager, Clinical Product Quality - Medical Device/Complaint Handling & Cardiovascular RN
$145K - $205K *
Lead the charge in ensuring product quality by guiding clinical investigations and complaint management. Collaborate with cross-functional teams to analyze data, assess health risks, and drive improve...
3 days ago
What does a Senior Regulatory Affairs Specialist do?
Senior Regulatory Affairs Specialists ensure product compliance with regulatory agencies. They compile and submit documentation required for clearance, perform internal audits, and ensure the business adheres to relevant laws and regulations.
What skills are needed for a Senior Regulatory Affairs Specialist job?
Key skills include knowledge of regulatory requirements, strong analytical and communication skills, attention to detail, and a commitment to continuous learning.
Where can I find Senior Regulatory Affairs Specialist jobs?
You can find top Senior Regulatory Affairs Specialist jobs that pay $100k and up on Ladders.
How can I progress in a Senior Regulatory Affairs Specialist career?
Progression can be achieved through continuous learning, keeping abreast of changes in regulations, obtaining relevant certifications, and gaining experience in various regulatory affairs roles.