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.
$95K - $115K *
Elevate your career with this hands-on role, supporting testing processes and validation in a regulated lab environment. Lead projects, mentor staff, and ensure compliance while driving innovation in...
1 week ago
Contracts Manager, Clinical Supply Services
$122K - $160K *
Accelerate your career by leading negotiations for strategic contracts, aligning commercial goals with legal standards. Partner across teams to support growth, mitigate risks, and enhance customer sat...
Reposted 3 days ago
Contracts Manager, Clinical Supply Services
$122K - $160K *
Drive commercial contract negotiations with a focus on growth, alignment, and risk management across global teams, enhancing client satisfaction and organizational objectives in a fast-paced, collabor...
Reposted 3 days ago
Senior Product Quality Engineer - Roadrunner
$126K - $167K *
Transform the future of defense by ensuring product quality in high-volume manufacturing. Collaborate across teams to define, implement, and refine processes that enhance performance and reliability o...
2 days ago
Supervisor, Quality Systems & Document Control
$80K - $95K *
Lead the continuous improvement of quality systems administration, ensuring compliance and data integrity across the organization. Oversee key workflows and manage a team dedicated to quality document...
4 weeks ago
Manufacturing Project Specialist
$85K - $100K *
Engage in the manufacturing readiness process to ensure efficient campaign delivery. Collaborate with teams to optimize practices, manage improvement projects, and uphold quality and safety standards...
2 weeks ago
Associate Research Scientist (Quality Assurance Lead)
$80K - $128K *
Join a team that's dedicated to advancing health services research while leading QA efforts, guiding projects, and influencing policy. Collaborate with experts to ensure quality and drive impactful re...
4 weeks ago
Associate Research Scientist (Quality Assurance Lead)
$80K - $128K *
Contribute to advancing health services research through quality assurance and methodology oversight. Lead automation efforts and research initiatives while promoting collaboration across teams to enh...
4 weeks ago
Associate Director, Legal-Compliance
$173K - $225K *
Grow your career with a leadership role driving compliance initiatives, enhancing auditing processes, and collaborating cross-functionally to ensure adherence to healthcare regulations while fostering...
3 weeks ago
Specialist, Engineering (Energy & Sustainability)
$87K - $137K *
Make your mark at a dynamic team focused on advancing energy & sustainability initiatives. Lead strategies, manage budgets, and optimize operations to enhance site performance while fostering a cultur...
4 days ago
$110K - $165K *
Deliver innovative electrical engineering solutions for diverse capital projects, focusing on healthcare facilities. Lead and mentor teams through design phases, ensuring compliance, quality, and clie...
1 week ago
$80K - $95K *
Join a dynamic QA team to review GMP documentation, ensuring compliance and quality in manufacturing and validation processes. Contribute your expertise in documentation management while collaborating...
1 week ago
$148K - $164K *
Join a dynamic team to advance weapon systems engineering, performing comprehensive system development, analysis, and integration for cutting-edge military technologies while ensuring timely and effic...
3 days ago
$110K - $130K *
Drive the continuous enhancement of the Aseptic Observer Program, ensuring compliance and quality in sterile manufacturing operations, while fostering teamwork and adherence to safety and quality stan...
1 week ago
Senior Manager, Regulatory Compliance Mgt. - Quality Assurance Review
$100K - $120K *
Shape the future by leading a dynamic team to ensure compliance with regulatory standards, driving quality assurance reviews to uphold high standards across global operations and effectively managing...
4 days ago
$105K - $129K *
Transform chemical regulatory practices by managing project deliverables, collaborating with teams, and providing regulatory expertise for diverse clientele while ensuring compliance with environmenta...
1 week ago
Senior Scientist I, Mechanical Engineering
$95K - $115K *
Empower our innovative team by designing and advancing complex instrumentation for peptide discovery, enhancing pharmaceutical development and improving patient outcomes through collaboration and crea...
1 week ago
Senior Associate Quality Assurance / Aseptic Coach
$82K - $111K *
Optimize quality assurance processes, ensuring compliance with GMP and regulatory standards in a fast-paced Drug Product manufacturing facility. Collaborate closely with teams to enhance aseptic pract...
4 weeks ago
Specialist / Sr. Specialist, PSRA, Americas
$100K - $125K *
Unlock potential by driving product safety and regulatory compliance efforts globally. Join a dynamic team to lead compliance strategy, streamline operations, and ensure safe product stewardship throu...
3 weeks ago
Senior Clinical Drug Supply Manager
$170K - $190K *
Tackle complex global clinical trial logistics, ensuring drug supply and compliance. Collaborate with cross-functional teams to lead supply chain operations, manage budgets, and drive improvements whi...
3 weeks ago
$160K - $260K *
Shape the future of cGMP compliance by leading quality assurance initiatives across US sites. Collaborate with cross-functional teams to ensure regulatory adherence and prepare for inspections, drivin...
Reposted yesterday
$164K - $205K *
Take ownership of the safety science and pharmacovigilance for clinical products, ensuring compliance and risk management while collaborating cross-functionally to support effective study oversight an...
1 week ago
Senior Specialist, CAR-T Lifecycle Management
$81K - $99K *
Unlock potential by overseeing CAR-T lifecycle activities and driving process innovation. Collaborate cross-functionally to enhance manufacturing strategies, develop project plans, and ensure complian...
Today
Quality Systems Engineer - CAPA and Process Improvement
$80K - $95K *
Manage the CAPA process from initiation to closure, ensuring compliance with regulatory standards. Collaborate across teams to identify issues, develop solutions, and drive continuous improvement whil...
2 weeks ago
Sr. Manager QA, Quality Systems & Product Complaints
$165K - $225K *
Lead the charge in ensuring quality oversight, compliance, and product complaint management. Drive CAPA program effectiveness and inspection readiness while collaborating with cross-functional teams t...
2 weeks 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.