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.
$78K - $122K *
Engage with cross-functional teams to drive enhancements and ensure compliance of medical devices throughout their lifecycle. Support technical investigations, product improvements, and sustain engine...
4 days ago
$78K - $122K *
Drive innovative product development from concept to launch, applying your technical expertise to design solutions and collaborate with cross-functional teams in the medical device industry...
1 week ago
$78K - $122K *
Drive innovative product development from concept to production as you leverage your technical expertise and customer-centric vision. Collaborate with cross-functional teams to enhance product offerin...
1 week ago
Sr. Clinical Research Associate
$135K - $150K *
Join our team to lead clinical trial activities for innovative treatments. This role involves managing clinical studies, ensuring compliance, and collaborating with cross-functional teams to drive pro...
Reposted 3 days ago
$200K - $225K *
Unlock potential by leading global quality compliance for pharmaceutical products. Drive audit excellence, manage inspection readiness, and partner with teams to ensure adherence to regulations while...
3 days ago
Senior Product Compliance Engineer
$90K - $125K *
Join a team that's committed to elevating product safety through compliance testing, ensuring designs adhere to rigorous international standards and regulations while collaborating across functions to...
3 weeks ago
$95K - $115K *
Join a team that's dedicated to driving operational excellence through Lean and Six Sigma methodologies. Lead improvement initiatives, enhance product quality, and foster collaboration across departme...
3 weeks ago
$95K - $115K *
Drive innovation in product development as a Senior R&D Scientist, leading pre-formulation studies, optimization, and stability evaluations while ensuring compliance and effective communication across...
3 weeks ago
Senior Scientist I, Quality Control
$155K - $160K *
Transform analytical capabilities in a biotech firm by executing complex QC assays and ensuring reliable product consistency. Collaborate cross-functionally while leading training initiatives and refi...
4 days ago
Senior Manager, Quality Operations (Onsite)
$155K - $259K *
Lead the charge in enhancing quality operations and systems, ensuring compliance and performance across functions to support patient safety. Drive continuous improvement initiatives and manage a high...
Reposted 3 weeks ago
Senior Manager, Quality Operations (Onsite)
$155K - $259K *
Champion quality excellence and compliance by leading a skilled team to drive performance improvement, collaborate cross-functionally, and uphold patient safety in a regulated environment. Guide initi...
Reposted 3 weeks ago
INGENYX- Senior Quality Engineer - Sterility Assurance & Validation
$115K - $140K *
Transform the quality landscape by serving as the technical authority for sterility assurance and validation. Support sterilization processes and ensure compliance while driving quality engineering in...
4 days ago
$80K - $95K *
Accelerate your career by driving pharmaceutical product development through advanced analytics and method validation. Thrive in a dynamic lab environment while utilizing various biochemical testing t...
1 week ago
Supervisor Quality Control, Analytical Laboratory
$81K - $112K *
Drive operational excellence in QC Analytical Lab by leading testing activities, ensuring compliance with regulations, mentoring staff, and managing resources to support product releases and process v...
3 days ago
Senior Scientist I Analytical Development
$112K - $135K *
Lead the charge in analytical development for small molecule CMC projects, enhancing quality control and regulatory compliance from preclinical through late-stage clinical phases, while collaborating...
Reposted 1 week ago
$100K - $120K *
Lead the charge in regulatory strategy for Latin America, coordinating submissions and ensuring compliance with local requirements while collaborating with cross-functional teams on best practices in...
Yesterday
Senior Manager, Supplier Quality - Contract Manufacturing (CMO)
$139K - $196K *
Elevate supplier quality by leading a high-performing team to enhance compliance, manage risks, and improve quality systems across contract manufacturers with a focus on medical devices and stakeholde...
Reposted 2 weeks ago
Senior Scientist - Biotransformation
$64K - $133K *
Lead the charge in conducting biotransformation studies, ensuring precise data analysis and collaboration across scientific teams to support drug metabolite research and regulatory compliance, while m...
4 weeks ago
Senior Systems Engineer (ABD - MDA)
$110K - $130K *
Lead the integration of missile defense systems, ensuring interoperability and alignment with national defense objectives. Collaborate across teams to support critical capabilities in a dynamic enviro...
5 days ago
$120K - $171K *
Join our mission to enhance public health by leading our B2B e-commerce platforms. Leverage your strategic product leadership to define customer-centric capabilities that drive seamless digital experi...
3 weeks ago
$95K - $115K *
Lead the charge in enhancing quality assurance and regulatory compliance across regional operations. Drive best practices, cultivate talent, and ensure top-tier performance in project execution while...
4 days ago
$95K - $124K *
Help us deliver accurate EMC test results while adhering to global standards. Collaborate with clients and team members to ensure quality compliance and support a positive work environment. Embrace a...
3 weeks ago
Senior Sanctions & Financial Systems Specialist
$98K - $163K *
Transform financial sanctions compliance by analyzing complex licensing requests. Collaborate with diverse teams to enhance operational efficiency and reduce backlogs while supporting OFAC's mission t...
Reposted 1 week ago
$100K - $150K *
Reimagine engineering documentation management by ensuring compliance, accuracy, and timely release throughout the product lifecycle. Collaborate with cross-functional teams to drive improvements and...
2 weeks ago
$120K - $145K *
Join a dynamic team to oversee cGMP compliance, QA/QC testing, and management of quality assurance systems for dietary and medical products. Make impactful decisions on quality compliance and foster i...
Reposted 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.