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.
$66K - $108K *
Transform quality assurance processes by investigating non-conformances and ensuring compliance with cGMP standards. Collaborate across teams to implement corrective actions and drive efficiency in ma...
Reposted 1 week ago
$154K - $231K *
Partner with us to lead regulatory operations and technical communications, driving compliance and operational excellence while managing a multidisciplinary team dedicated to improving practices and s...
1 week ago
Sr Legal Operations Specialist, Compliance Programs & Controls
$90K - $120K *
Drive compliance excellence by optimizing trade diversion risk processes and controls. Collaborate with Legal, IT, and Finance to streamline workflows and enhance visibility, ensuring operational effi...
2 weeks ago
Senior Quality Management Systems Specialist (US Citizen) - Camden, NJ - 5037
$85K - $110K *
Play a key role in enhancing quality management systems through auditing, compliance, and documentation control, ensuring adherence to AS9100 and ISO standards across an aerospace and defense environm...
Reposted 6 days ago
Sr. Manager Global Regulatory Strategy
$120K - $150K *
Contribute to global regulatory strategies for groundbreaking contact lens technologies, guiding cross-functional teams and establishing engagement with health authorities to drive innovation and ensu...
Reposted 5 days ago
$80K - $100K *
Unlock potential by enhancing supplier quality through strategic metrics, improving processes, and fostering strong supplier relationships to drive operational excellence and adherence to standards wh...
5 days ago
Regulatory Compliance Engineer
$80K - $110K *
Engage in enhancing tax compliance accuracy through diligent quality assurance of tax engines and rules. Develop expertise in indirect tax regulations and improve testing workflows in a collaborative...
Reposted today
Senior Principal Quality Engineer - Design Quality & Systems Excellence
$122K - $212K *
Join a team transforming medical device quality excellence. Lead design quality initiatives, ensuring robust and compliant products while driving cross-functional collaboration to enhance reliability...
Reposted 1 week ago
Principal Analytical QA Specialist, Drug Substance
$150K - $190K *
Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...
2 days ago
Senior Manager, Global Development Quality Assurance (GCP)
$134K - $219K *
Engage in leading GCP audit programs, managing staff development, and implementing quality initiatives to enhance safety compliance. Contribute to a dynamic, science-focused environment dedicated to i...
2 weeks ago
Manager - Regulatory Affairs (Remote)
$124K - $152K *
Unlock potential by leading regulatory strategies for in vitro diagnostics, ensuring compliance and effective submissions, while collaborating with cross-functional teams to manage product development...
3 days ago
Manager - Regulatory Affairs (Remote)
$124K - $152K *
Champion regulatory excellence by leading compliance initiatives and submission strategies for in vitro diagnostics, ensuring adherence to U.S. and European regulations while partnering with cross-fun...
1 week ago
Senior Manager, Sterility Assurance
$121K - $146K *
Transform the field of cell therapy by managing critical Sterility Assurance initiatives, supporting facility design, validating aseptic processes, and leading contamination control strategies within...
Reposted 1 week ago
Manager, Regulatory Affairs - Tactical Implementation
$133K - $173K *
Unlock your potential as a Manager in Regulatory Affairs focused on executing and overseeing global submission activities. Collaborate with cross-functional teams to ensure compliance, enhance process...
Yesterday
Global Regulatory & Compliance Specialist
$80K - $102K *
Transform global regulatory compliance by ensuring product safety and market readiness through collaboration with cross-functional teams. Drive risk mitigation with strong systems, documentation, and...
3 weeks ago
Senior Quality Validation Engineer
$138K - $148K *
Lead the charge in validation initiatives for sterile injectable manufacturing. Ensure compliance with regulatory standards while mentoring junior engineers. Collaborate across functions to drive effi...
3 weeks ago
QC Laboratory Instrument, Senior Specialist
$106K - $167K *
Transform laboratory operations by leading analytical instrumentation projects and lifecycle management, ensuring compliance and driving innovation in a regulated environment while mentoring junior sp...
Reposted 1 week ago
Director/Senior Director, Regulatory Affairs
$230K - $300K *
Join a team that's driving regulatory strategy for a leading product across multiple global markets. Oversee submissions and compliance, ensuring alignment with regulations while collaborating on prod...
1 week ago
Senior Regulatory Compliance Leader
$100K - $130K *
Transform regulatory compliance practices in Arizona, leading a talented team while driving client success nationally. Leverage extensive expertise and strong leadership to enhance environmental servi...
5 days ago
$128K - $143K *
Lead the charge in regulatory excellence by providing advanced technical expertise and problem-solving in support of nuclear plant operations. Drive compliance, enhance performance, and influence indu...
3 weeks ago
$128K - $143K *
Unlock potential by leading regulatory analysis and technical problem-solving in the nuclear sector. Leverage your expertise to ensure compliance, enhance operations, and support critical projects tha...
3 weeks ago
Senior Regulatory Compliance Leader
$100K - $130K *
Drive regulatory compliance initiatives by leading strategies, mentoring staff, and engaging clients to enhance environmental services across Arizona and nationally, ensuring adherence to regulations...
5 days ago
Senior Regulatory Compliance Leader
$100K - $130K *
Create impactful environmental strategies by leading regulatory compliance initiatives, mentoring teams, and developing client relationships to ensure adherence to standards and promote sustainability...
5 days ago
$73K - $91K *
Join a team that's dedicated to ensuring regulatory compliance across functions. Lead submission preparation, provide guidance on protocols, and drive continuous improvement efforts, playing a key rol...
2 weeks ago
Associate Director, Global Regulatory Affairs Marketed Products
$154K - $242K *
Drive your career by leading global regulatory strategies for complex projects, ensuring compliance, and enhancing patient access to innovative therapies. Collaborate cross-functionally to influence k...
Reposted 3 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.