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 Specialist, Procurement
$95K - $110K *
Drive strategic procurement initiatives across North America, enhancing vendor relationships and improving service quality. Collaborate with teams to execute cost-saving projects and ensure operationa...
3 weeks ago
Senior Specialist, Procurement
$95K - $110K *
Lead the charge in transforming procurement processes while ensuring compliance and driving efficiency across North America. Collaborate with vendors and internal teams to enhance supplier performance...
3 weeks ago
Senior Manager, Compliance - Field Commercialization (West)
$164K - $205K *
Unlock your potential by partnering with Commercial teams to implement compliance initiatives, deliver training, and support policy development. Guide field activities and ensure adherence to regulati...
5 days ago
Senior Quality Systems Auditor
$126K - $138K *
Lead internal quality audits to ensure compliance with ISO 13485 and FDA regulations. Play a key role in improving QMS processes, managing audit findings, and supporting certification efforts within t...
5 days ago
Senior Director, Regulatory Affairs (Ad Promo)
$215K - $296K *
Unlock potential by leading regulatory affairs for advertising and promotions. Drive compliance with US and Canadian regulations while guiding cross-functional teams to achieve strategic business obje...
5 days ago
$87K - $137K *
Lead the charge in delivering exceptional laboratory support by managing sample tracking, scheduling, and performance metrics while fostering collaboration and continuous improvement in a team-oriente...
1 week ago
Senior Specialist - Medical Events Group
$90K - $180K *
Analyze and document medical device reports for regulatory compliance, ensuring they meet international standards. Collaborate with cross-functional teams to drive improvements in processes and suppor...
3 weeks ago
Senior Operational Quality Assurance Specialist
$90K - $120K *
Contribute to quality assurance excellence in regulated biotech environments. Ensure compliance through audits, batch releases, and documentation management while embracing continuous improvement in o...
1 week ago
Senior Specialist - Medical Events Group
$90K - $180K *
Accelerate progress at our Diabetes Care division by ensuring compliance with medical reporting regulations, documenting medical events, and collaborating with cross-functional teams to enhance produc...
3 weeks ago
Associate Director, Compliance - Field Commercialization
$186K - $233K *
Pioneer your compliance career by leading field compliance strategies that enhance organizational effectiveness while mitigating risks during product commercialization and expansion in a dynamic bioph...
3 weeks ago
Quality Engineer 3 - Risk Management
$98K - $154K *
Innovate by driving product and process risk management for medical devices throughout their lifecycle. Collaborate across teams to ensure compliance with FDA and ISO standards while supporting qualit...
3 weeks ago
Executive Director, Regulatory Affairs
$180K - $220K *
Innovate global regulatory strategies for oncology, overseeing development lifecycle from early clinical through commercialization, ensuring alignment with corporate goals and leading cross-functional...
Reposted 1 week ago
Associate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998
$185K - $205K *
Innovate global regulatory strategies for complex clinical and CMC submissions. Collaborate with cross-functional teams while mentoring peers. This role requires both independent work and teamwork to...
4 days ago
Principal Regulatory Affairs Specialist: Pelvic Health
$120K - $180K *
Drive innovative global regulatory strategies and clinical trial applications for high-risk medical devices. Collaborate cross-functionally to ensure compliance and optimize clinical study processes...
Reposted 2 days ago
Product Quality Assurance Supervisor
$75K - $95K *
Advance quality assurance excellence by leading AQL programs and real-time GMP compliance. Supervise QA teams and foster collaboration across manufacturing, ensuring adherence to standards and continu...
Today
Senior Supplier Quality Engineer - SFMD
$85K - $161K *
Elevate quality assurance across diverse suppliers in finished medical device manufacturing. Collaborate and lead initiatives to ensure compliance, enhance processes, and prioritize patient safety wit...
1 week ago
$150K - $180K *
Unlock potential by leading Quality Operations across the Kansas City campus, ensuring compliance with industry standards, implementing strategic plans, and promoting a culture of continuous improveme...
Reposted 2 weeks ago
Senior AR Specialist - Dispute and Collection
$74K - $132K *
Join a dynamic team managing a $20-25M accounts receivable portfolio, focusing on dispute resolution and collections. Collaborate with internal and external teams to enhance cash flow while delivering...
Reposted yesterday
Construction Quality Assurance Manager (GSA / Design-Build)
$80K - $110K *
Oversee and ensure quality compliance for federal HVAC and electrical upgrade projects, managing inspections and adherence to GSA standards while collaborating closely with contractors and government...
Yesterday
Sr Engineer- Process Development (CQV)
$85K - $110K *
Take ownership of validating automated systems within GMP environments, ensuring compliance with FDA standards and driving operational excellence through collaboration with cross-functional teams in m...
5 days ago
Direct Materials Regulatory Filings Principal Expert
$114K - $212K *
Architect global compliance strategies for Direct Materials Certification. Lead modernization, streamline processes across Biologics and Molecules, and resolve complex regulatory challenges while ensu...
Yesterday
Direct Materials Regulatory Filings Principal Expert
$114K - $212K *
Architect enterprise-level Direct Materials Certification strategies, ensuring compliance and driving modernization. Influence stakeholders to solve regulatory challenges and enhance supply chain flex...
Yesterday
$100K - $130K *
Champion regulatory excellence by leading submissions and ensuring compliance with FDA guidelines while collaborating with cross-functional teams to support innovative biopharmaceutical products...
Reposted 6 days ago
Senior MES Engineer, CVRM (Holly Springs)
$78K - $146K *
Join a team that's implementing advanced Manufacturing Execution Systems to support cutting-edge drug product manufacturing. Engage in greenfield project execution, ensuring operational excellence and...
Reposted 5 days ago
Clinical Affairs Specialist, Interventional Coronary (REMOTE)
$92K - $139K *
Grow your career with a pivotal role that enhances clinical integration and product adoption through collaboration, education, and evidence-based insights to elevate patient care experiences across he...
4 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.