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.
Principal Regulatory Affairs Specialist
$150K - $180K *
Lead regulatory affairs across US, EU, and Japan for Class III medical devices, ensuring successful submissions and compliance while collaborating with cross-functional teams to navigate complex chall...
2 days ago
$80K - $95K *
Analyze regulatory landscapes to ensure compliance and facilitate product approvals across pharmaceutical and medical device sectors, collaborating with cross-functional teams to drive successful subm...
Reposted yesterday
$80K - $95K *
Tackle regulatory challenges by ensuring compliance and supporting submissions in the healthcare and biotechnology sectors. Collaborate with diverse teams to facilitate product approvals while monitor...
2 weeks ago
$80K - $95K *
Drive global regulatory compliance and product registration for medical devices. Coordinate submissions and maintain documentation while collaborating with internal and external stakeholders to ensure...
2 weeks ago
Senior Director of Regulatory Affairs
$125K - $225K *
Shape the future of regulatory affairs by leading strategic initiatives for IVD and LDT products. Collaborate across functions to ensure compliance, oversee submissions, and maintain product integrity...
3 weeks ago
Senior / Regulatory Affairs Consultant - Regulatory Labeling Strategist
$120K - $145K *
Drive global regulatory labeling initiatives, ensuring compliance and quality of documentation across diverse markets. Lead strategic governance, influence policies, and collaborate cross-functionally...
2 weeks ago
Spécialiste, Affaires Réglementaires | Specialist, Regulatory Affairs
$80K - $95K *
Join a team that's at the forefront of regulatory compliance, preparing submissions and communicating with health authorities. Contribute to maintaining licenses while ensuring adherence to industry s...
5 days ago
Regulatory Affairs Specialist II - Labeling & Promotion
$80K - $95K *
Drive the compliance of labeling and promotional materials to enhance regulatory standards while preparing eCTD submissions and collaborating with cross-functional teams on product development and reg...
1 month ago
$145K - $165K *
Drive regulatory CMC strategies and submissions for generic drugs, ensuring compliance with FDA regulations. Collaborate with cross-functional teams to facilitate timely approvals throughout the produ...
Reposted 1 week ago
$71K - $119K *
Engage in regulatory strategy development and submissions for software products across global markets. Collaborate with cross-functional teams to ensure compliance and approve documentation for innova...
6 days ago
Senior Manager, Regulatory Affairs Advertising and Promotion
$122K - $176K *
Unlock potential by overseeing regulatory strategies for advertising and promotional materials. Collaborate with cross-functional teams and serve as a key liaison with the FDA to ensure compliance and...
Reposted yesterday
Senior Manager, Regulatory Affairs Advertising and Promotion
$122K - $176K *
Lead the charge in regulatory affairs, driving compliance for advertising and promotional campaigns. Collaborate with cross-functional teams to craft strategies that ensure effective communication whi...
Reposted yesterday
Director, International Regulatory Affairs #4809
$169K - $242K *
Lead the charge in global regulatory strategy, overseeing diagnostics and device commercialization. Collaborate with executive leadership to influence policy and ensure compliance across multiple mark...
Reposted 2 weeks ago
Regulatory Affairs Consultant - Submissions Manager
$110K - $130K *
Shape the future of regulatory submissions through strategic management, collaboration, and expert oversight. Lead cross-functional teams in delivering compliant submissions to global health authoriti...
2 weeks ago
Senior Global Regulatory Manager
$125K - $150K *
Lead the charge in global regulatory excellence, ensuring compliance and optimizing quality management systems across multiple regions while fostering collaboration and driving initiatives that enhanc...
2 weeks ago
Senior Global Regulatory Manager
$125K - $150K *
Innovate robust global regulatory frameworks to enhance compliance, drive quality initiatives, and support strategic goals across diverse teams while ensuring adherence to international standards and...
2 weeks ago
Senior Manager, Regulatory Affairs CMC (Oncology)
$156K - $195K *
Unlock potential by leading regulatory CMC strategies for oncology products, coordinating submissions, and collaborating across teams to ensure compliance and successful product registration in a dyna...
3 weeks ago
Senior Regulatory Strategist, Advertising & Promotion (work from home)
$125K - $150K *
Drive regulatory strategy by collaborating cross-functionally to influence promotional activities, ensuring compliance while optimizing risk management for impactful business decisions across a dedica...
2 weeks ago
Associate Director, Regulatory Affairs
$170K - $231K *
Transform your career as you lead regulatory strategies for innovative programs, collaborating with cross-functional teams to navigate FDA submissions and ensure compliance while impacting drug develo...
1 week ago
Associate Director, Regulatory Affairs
$170K - $231K *
Lead the charge in regulatory strategy and submissions for product development, ensuring compliance with US and international health authority requirements while guiding cross-functional teams in the...
1 week ago
Sr Manager, Regulatory Operations
$145K - $241K *
Drive compliance and efficiency in regulatory operations, overseeing labeling, post-market reporting, and UDI governance. Lead a team to ensure global adherence to standards, enhancing processes for a...
1 week ago
Sr Manager, Regulatory Operations
$145K - $241K *
Transform regulatory operations by providing strategic leadership for global compliance and efficient processes across medical device labeling, reporting, and governance, while managing a skilled team...
1 week ago
$95K - $115K *
Accelerate compliance excellence by managing Quality Assurance processes, ensuring audit readiness, and driving corrective actions in the pharmaceutical industry. Collaborate cross-functionally to mai...
2 weeks ago
Senior Quality Systems Specialist
$95K - $115K *
Champion quality systems transformation by enhancing documentation, investigations, and compliance processes. Drive continuous improvement and strengthen standards across operations to ensure clarity...
Reposted 2 days ago
Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery
$125K - $201K *
Lead the charge in regulatory strategy for innovative surgical technologies, collaborating cross-functionally to achieve global market access and support product development within a dynamic and growt...
Reposted 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.