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.
INGENYX- Sr. Quality Engineer, Devices
$127K - $190K *
Deliver high-impact quality engineering leadership for complex medical device projects, ensuring compliance and process excellence. Collaborate across teams to solve challenges, enhance patient safety...
2 weeks ago
Associate Scientist, Potency Assay Development
$70K - $110K *
Build impactful gene therapy solutions by developing and optimizing cell-based assays. Collaborate cross-functionally to enhance preclinical and clinical programs, ensuring robust assay transfer to GM...
Reposted 3 days ago
Senior Staff R&D Systems Engineer- Electro-Mechanical & Fluidic Systems
$118K - $196K *
Transform the future of medical devices by leading R&D in developing advanced vascular thrombectomy platforms. Collaborate across functions to design, test, and optimize innovative solutions that enha...
1 week ago
$58K - $122K *
Join a team that's vital to our procurement operations, leading sourcing, negotiation, and management of contracts for material and service needs while ensuring compliance with regulatory standards an...
2 days ago
Bioassay Development Senior Scientist
$100K - $145K *
Champion innovative bioassay methods and lead cross-functional teams in developing early and late-stage clinical molecules, ensuring GMP compliance and best practices in a dynamic lab environment...
Today
$120K - $185K *
Collaborate with clinical and sales teams to enhance product support and deliver tailored healthcare solutions, engaging with clients and internal stakeholders to foster strong partnerships and achiev...
2 weeks ago
Senior Director, Clinical Operations
$180K - $220K *
Lead the charge in clinical operations, providing strategic oversight to project teams, optimizing resources, and ensuring compliance and profitability while fostering collaboration and development wi...
Reposted 2 weeks ago
Senior Supplier Quality Engineer - Grand Rapids, MI
$99K - $148K *
Analyze and manage supplier quality performance, ensuring compliance with regulatory standards and operational requirements while driving continuous improvement in manufacturing processes and product...
2 days ago
$80K - $95K *
Shape the future of procurement by managing vendor relationships, executing purchase orders, and leading negotiations. Drive strategic cost savings while ensuring quality and timely delivery within a...
2 weeks ago
$95K - $115K *
Explore opportunities to innovate and lead product development in hematology and urinalysis. Collaborate with cross-functional teams to enhance next-generation reagents, ensuring quality and complianc...
3 weeks ago
$95K - $115K *
Champion innovation in hematology and urinalysis products by leading R&D efforts, developing new methodologies, and optimizing designs to deliver high-quality consumables while collaborating in an agi...
3 weeks ago
$110K - $129K *
Join a team that's committed to quality excellence by managing our Quality Management System, ensuring compliance with ISO 13485, and fostering cross-functional collaboration to drive continuous impro...
Reposted 4 weeks ago
Assistant/Associate Director, Pharmacovigilance Quality Assurance
$121K - $196K *
Champion a comprehensive GVP quality program, partnering with multiple departments to ensure compliance through audits, training, and continuous improvement initiatives. Your expertise will enhance op...
1 month ago
Senior Product Quality Engineer - Barracuda
$146K - $194K *
Elevate product quality for missile programs by executing rigorous processes, collaborating cross-functionally, and driving continuous improvement to ensure high performance and reliability throughout...
3 days ago
$66K - $124K *
Execute hands-on drug product manufacturing while ensuring compliance and safety. Collaborate with Operations and Quality teams to troubleshoot processes and maintain aseptic techniques in a regulated...
Reposted 2 weeks ago
Risk Manager (Pharmaceutical Construction)
$110K - $130K *
Lead the charge in risk management by delivering QRA workshops and collaborating with stakeholders to evaluate project risks, while developing impactful assessment strategies and fostering business gr...
1 week ago
$103K - $218K *
Transform quality management by leading the development and implementation of comprehensive strategies driving performance excellence across large-scale programs, ensuring compliance with government s...
3 days ago
$80K - $95K *
Join a dynamic team as a Senior Benefits Specialist, overseeing U.S. employee benefit programs, leave administration, and compliance. Drive process improvements and enhance employee engagement through...
4 days ago
Senior Manager, Contracts Administration
$112K - $179K *
Unlock potential by leading complex contract negotiations and managing strategic initiatives. Collaborate with executives, provide legal guidance, and foster customer relationships while ensuring comp...
3 weeks ago
Validation Engineer (Onsite - Columbia, MO)
$106K - $145K *
Transform the quality landscape by validating medical devices and drug processes. Engage in protocol development, ensure regulatory compliance, and foster cross-functional collaboration to guarantee e...
2 weeks ago
$95K - $115K *
Lead the charge in the design and implementation of electrical power distribution systems for Gas Turbine projects, ensuring compliance with industry standards and codes while mentoring junior enginee...
3 weeks ago
Supervisor Quality Control, Microbiology
$81K - $112K *
Transform your leadership skills by overseeing QC Microbiology Lab operations, ensuring regulatory compliance and fostering a culture of continuous improvement. Guide foundational microbiological test...
4 days ago
$85K - $100K *
Grow your career with a role that coordinates quality assurance efforts for major projects. Engage in disciplined problem-solving, ensure compliance, and support design control from concept to release...
2 weeks ago
6513 - Senior Validation Engineer / Senior CQV Engineer
$78K - $128K *
Unlock your potential in a dynamic role focusing on technical validation and support for critical equipment and processes, ensuring compliance and excellence in a collaborative team environment...
3 days ago
$95K - $115K *
Support quality assurance and validation processes in manufacturing transfers, focusing on compliance, supplier quality, and continuous improvement to ensure excellence in product and process reliabil...
Reposted 6 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.