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.
Senior Regulatory Affairs Associate - Generalist
$100K - $120K *
Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...
Reposted 2 weeks ago
$85K - $100K *
Elevate regulatory standards by coordinating global submissions for medical devices, ensuring compliance with U.S. and international guidelines while supporting cross-functional collaboration and stra...
1 week ago
Senior Regulatory Affairs Specialist
$83K - $103K *
Drive success in regulatory affairs by preparing critical submissions for medical and diagnostic devices. Oversee compliance with U.S. and international regulations while collaborating with cross-func...
Reposted 2 days ago
Senior Manager, Regulatory Affairs
$139K - $184K *
Join a team that's committed to driving innovative regulatory projects, ensuring compliance, and collaborating with cross-functional teams to secure timely submissions and approvals for products in th...
5 days ago
Senior Regulatory Affairs Program Lead (OTTAVA) - MedTech Surgery
$125K - $201K *
Take ownership of regulatory strategy development for robotic systems, ensuring compliance and timely submissions. Collaborate with engineering and clinical teams to drive project success in securing...
4 days ago
Associate Director, Global Regulatory Affairs
$155K - $190K *
Join a team that's shaping the future of global regulatory affairs. You will lead compliance strategies for investigational products and marketing applications through effective submissions and collab...
2 weeks ago
Regulatory Affairs Consultant - CMC Biologics / Plasma Products
$110K - $130K *
Join a dynamic team as you drive regulatory strategies and ensure compliance in post-approval activities for CMC processes. Collaborate cross-functionally, influencing clinical outcomes and advancing...
1 week ago
Senior Manager, Clinical Regulatory Affairs
$159K - $202K *
Lead regulatory strategy for innovative CAR T and gene therapy programs, ensuring compliant submissions and fostering collaboration across cross-functional teams to navigate complex clinical landscape...
2 weeks ago
Regulatory Compliance Engineer II
$85K - $125K *
Shape compliance strategies across hardware and biotech sectors, ensuring products meet global regulatory standards and collaborating with cross-functional teams to drive innovative solutions and main...
Reposted 2 weeks ago
Senior Regulatory Affairs Specialist
$92K - $138K *
Champion global regulatory strategies by leading diverse teams in navigating complex approval processes for medical devices. Drive compliance and ensure optimal product launch pathways while addressin...
Reposted 1 week ago
Senior Regulatory Affairs Specialist
$92K - $138K *
Transform regulatory landscapes by leading critical global projects to secure and maintain approvals for medical devices, while guiding teams in navigating complex compliance requirements and strategi...
2 weeks ago
Associate Director, Regulatory Operations
$172K - $210K *
Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...
1 week ago
Associate Director, Regulatory Affairs, AD Promo
$200K - $221K *
Join a team that's dedicated to ensuring compliance in promotional activities for CNS treatments while navigating regulatory pathways in a fast-paced environment. Help shape communications, drive stra...
4 weeks ago
Associate Director, Regulatory Affairs (Regulatory Intelligence)
$130K - $160K *
Advance your career by leading regulatory intelligence efforts, analyzing global developments, and providing strategic insights to ensure compliance. Collaborate cross-functionally to enhance processe...
6 days ago
Associate Director, Regulatory Affairs (Regulatory Intelligence)
$130K - $160K *
Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...
6 days ago
Senior Director, Regulatory Affairs
$211K - $281K *
Champion regulatory excellence by leading U.S. FDA engagement and strategy for product development, ensuring timely approvals and compliance while driving cross-functional collaboration and organizati...
2 days ago
$101K - $197K *
Empower your career by leading global regulatory strategies for medical devices and diagnostics. Collaborate with cross-functional teams to ensure compliance and drive market access while mentoring ot...
Today
Senior Associate - Regulatory Affairs
$83K - $113K *
Transform regulatory compliance by supporting submissions and documentation, ensuring adherence to standards, and collaborating with teams to navigate evolving regulations in a dynamic environment...
3 days ago
Senior Manager, Global Regulatory Affairs
$120K - $145K *
Drive regulatory strategies and oversee compliance for investigational therapies. Work cross-functionally to ensure timely regulatory filings and maintain vendor relationships, contributing to clinica...
3 weeks ago
Senior Regulatory Data Manager, Nicotine Sciences
$110K - $130K *
Lead the planning and execution of regulatory data management for nicotine studies, ensuring data quality and compliance from protocol to reporting. Collaborate cross-functionally to uphold data integ...
Reposted 2 weeks ago
$154K - $165K *
Shape the future of medical devices by leading regulatory strategies, ensuring compliance across global markets, and mentoring a dedicated team. Empower innovation through effective communication with...
Reposted 1 week ago
Global Regulatory Affairs Portfolio Lead, Marketed Products, Radiopharma
$132K - $198K *
Collaborate with cross-functional teams to oversee regulatory activities for a portfolio of Pharmaceutical Diagnostics products, ensuring compliance and strategic alignment with global standards throu...
Reposted yesterday
AD / Director - Regulatory Affairs - FSP Team
$150K - $180K *
Deliver strategic regulatory leadership for global development programs, overseeing regulatory strategy and execution from late-stage clinical phases to marketing authorization while ensuring complian...
Reposted 1 week ago
Manager, Regulatory Affairs (Clinical Labeling)
$110K - $130K *
Take ownership of IMP labeling processes, ensuring compliance with global regulations and quality standards while collaborating cross-functionally to support clinical trial timelines and enhance label...
4 days ago
Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have
$56K - $115K *
Accelerate global regulatory CMC strategy and submissions for marketed products, ensuring compliance with FDA, EMA, Health Canada, and ICH guidelines. Collaborate cross-functionally as a primary conta...
1 week 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.