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.
$110K - $145K *
Unlock your potential as you drive legal operations, governance, and compliance initiatives in a dynamic corporate setting. Collaborate closely with legal teams and stakeholders to ensure effective ma...
Reposted 1 month ago
$95K - $115K *
Shape the future of GMP QC systems by leading implementation and integration activities. Oversee project execution, engage stakeholders, and ensure quality compliance by managing timelines and support...
Reposted 1 week ago
Sr. Engineer - F&E Environmental & Contamination Control
$115K - $156K *
Lead cross-functional investigations of technical deviations and ensure compliance in a dynamic environment. Drive corrective actions and documentation, supporting continuous improvement and operation...
1 month ago
Senior Service Sales Specialist
$85K - $104K *
Elevate sales performance by managing service contract renewals and conversion opportunities, driving revenue growth in North American territories through strategic customer engagement and exceptional...
3 weeks ago
$80K - $110K *
Elevate your career by ensuring equipment reliability and operational efficiency in a multi-product biologics facility. Bring your engineering skills to collaborate with teams in a dynamic environment...
Reposted 2 days ago
$80K - $110K *
Join a team that's committed to ensuring equipment reliability and efficiency in a multi-product facility through hands-on troubleshooting, preventive maintenance, and cross-functional collaboration t...
2 weeks ago
$85K - $116K *
Champion validation strategies and execute essential activities for manufacturing equipment, utilities, and processes in a bio-manufacturing environment, ensuring compliance and quality in product lif...
2 weeks ago
Reliability Engineering Manager
$145K - $165K *
Manage and enhance equipment reliability programs, ensuring operational excellence through solid engineering practices, compliance with cGMP, and collaboration with teams to drive performance improvem...
1 month ago
Senior Test Engineer (Hybrid Cary, IL)
$85K - $142K *
Transform the testing landscape by leading the design and execution of innovative test systems, ensuring product safety and performance, while supporting medical product development with a strong tech...
1 week ago
Senior Electrical & Control Designer 2 - Mission Critical
$85K - $130K *
Explore innovative design opportunities in high-stakes environments, contributing to advanced control systems and instrumentation through collaboration with a multi-disciplinary team, ensuring impactf...
1 week ago
Business Development Specialist
$97K - $130K *
Transform client engagement by building relationships and identifying new business opportunities in the biotech sector. Collaborate with cross-functional teams to advance innovative therapies and prov...
Reposted 3 weeks ago
Business Development Specialist
$97K - $130K *
Accelerate business growth by identifying new biotech opportunities and fostering client relationships, working closely with scientific and technical teams to drive innovative therapy solutions and en...
Reposted 3 weeks ago
Business Development Specialist
$103K - $138K *
Champion innovative biotechnology solutions by building key relationships and identifying opportunities in the US West region. Collaborate with diverse teams to expand market presence and drive busine...
3 weeks ago
Business Development Specialist
$103K - $138K *
Join a team that drives business development in biotechnology, enhancing awareness of life-changing therapies. Collaborate remotely with diverse teams to identify and engage potential clients across t...
3 weeks ago
$85K - $100K *
Discover a pivotal role in enhancing quality and compliance during supplier transitions for manufacturing. Collaborate across teams to ensure successful implementation and ongoing support of innovativ...
Reposted 1 week ago
$80K - $95K *
Unlock potential by leading supplier quality initiatives to enhance material integrity in fast-paced manufacturing. Drive corrective actions, manage non-conformance, and collaborate for process improv...
1 week ago
$80K - $95K *
Champion supplier quality excellence by leading investigations into non-conformances, driving corrective actions, and enhancing incoming material quality in a dynamic manufacturing environment through...
1 week ago
$88K - $105K *
Shape the future of quality engineering by leading supplier investigations, driving corrective actions, and enhancing material standards. Collaborate cross-functionally to ensure superior incoming mat...
2 weeks ago
Senior Engineer, Legal - Canada Remote
$150K - $180K *
Unlock innovative AI solutions for legal and compliance workflows, leveraging your expertise in software engineering and data science. Collaborate with stakeholders to transform processes, ensuring se...
4 days ago
Senior Supply Chain Specialist / Buyer - SAP
$88K - $105K *
Reimagine supply chain excellence as you lead procurement, enhance material flow, and drive operational efficiencies across multiple sites. Foster cross-functional collaboration to support production...
Reposted 1 week ago
Senior Product Quality Engineer - Altius
$126K - $167K *
Redefine product quality by driving high-rate manufacturing processes, ensuring reliability and performance across Altius systems. Collaborate with engineers and production teams to establish and exec...
3 days ago
$92K - $110K *
Join us to lead engineering initiatives and enhance manufacturing processes, ensuring product quality and operational excellence through innovative solutions and collaboration across teams to drive co...
3 days ago
Quality and Regulatory Manager
$85K - $100K *
Take ownership of quality and regulatory standards, ensuring medical devices excel from development to market. Lead audits, maintain ISO 13485 compliance, and collaborate cross-functionally to drive i...
2 weeks ago
$95K - $115K *
Optimize validation processes and collaborate with cross-functional teams to ensure compliance and support technology transitions. Drive project execution, improve documentation efforts, and enhance t...
1 week ago
Senior Mechanical Design Engineer
$95K - $115K *
Drive innovative mechanical designs and solutions in a collaborative engineering environment, managing multiple projects while mentoring team members to meet customer specifications and deadlines...
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.