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.
$90K - $115K *
Drive quality assurance by collaborating with suppliers to ensure optimal parts and materials, supporting new product development efforts, and fostering continuous improvement to meet healthcare indus...
1 week ago
Regulatory Affairs Specialist (FDA medical device regulation)
$70K - $95K *
Provide comprehensive Regulatory Affairs support to ensure full compliance with U.S. FDA medical device regulations and international standards, facilitating product submissions and ongoing industry c...
Today
Regulatory Affair Director - Global Regulatory Leader (Rare Disease)
$189K - $256K *
Engage as a Global Regulatory Leader, driving innovative regulatory strategies and interactions to streamline product development and global approval processes, while ensuring compliance and effective...
2 weeks ago
Senior Clinical Research Specialist
$80K - $110K *
Transform clinical trial management by maintaining essential documents and trackers, ensuring compliance with regulations, and supporting study teams throughout trial phases. Contribute to efficient o...
3 weeks ago
Sr. Validation & Compliance Engineer
$90K - $120K *
Join a team that's advancing validation activities in a regulated biotech environment. You'll manage CQV processes for equipment and facilities, ensuring compliance and collaboration across department...
3 days ago
$132K - $178K *
Partner with us to ensure continuous inspection readiness in a GMP environment, coordinating regulatory audits and inspections while supporting cross-functional teams to drive compliance and quality s...
6 days ago
Senior Manager / Associate Director, Regulatory Affairs CMC
$140K - $200K *
Engineer innovative CMC regulatory strategies to ensure compliance across product lifecycles. Collaborate with cross-functional teams to deliver high-quality submissions and expert guidance while main...
Today
Senior Manager / Associate Director, Regulatory Affairs CMC
$140K - $200K *
Join a team that's driving CMC regulatory strategies globally, ensuring compliance and integrity. Partner across functions to deliver high-quality submissions and navigate regulatory challenges effect...
Yesterday
$185K - $204K *
Champion cross-functional collaboration to drive quality assurance practices and enhance product development. Lead Design Assurance initiatives, ensuring compliance with regulatory standards while men...
3 weeks ago
Senior Manager, Regulatory Affairs
$144K - $185K *
Lead the charge in regulatory affairs across dietary supplements and consumer health products. Drive strategy, ensure compliance, and foster collaboration with key functions to navigate FDA and FTC re...
2 weeks ago
Sr Manager/Assoc Director, CMC Regulatory Affairs
$175K - $205K *
Deliver impactful CMC regulatory support for IND/CTA development and maintenance, ensuring compliance and completeness across submissions while leading cross-functional collaboration and strategically...
Today
Sr Manager/Assoc Director, CMC Regulatory Affairs
$175K - $205K *
Drive regulatory excellence by leading CMC activities for IND/CTA submissions and ensuring compliance across development phases, while collaborating cross-functionally to support innovative oncology p...
Today
Sr Manager/Assoc Director, CMC Regulatory Affairs
$175K - $205K *
Unlock potential by leading CMC regulatory activities for IND/CTA development. Drive compliance and quality in submissions, assess CMC changes, and collaborate cross-functionally to support clinical t...
Today
Sr. Regulatory Affairs Manager
$101K - $121K *
Innovate regulatory strategies to advance compliance and market access across food, animal feed, and plant care sectors in North America while ensuring quality and efficiency in regulatory operations...
2 weeks ago
Senior Design Quality Engineer
$90K - $120K *
Elevate product quality in medical device design by leading verification and validation, driving compliance, and collaborating across teams to enhance safety and risk management throughout the product...
3 weeks ago
$90K - $111K *
Optimize validation processes by executing complex protocols and managing projects. Utilize specialized knowledge in GMP manufacturing to support high-quality validation across diverse temperature-sen...
1 week ago
Usability and Regulatory Affairs Specialist
$90K - $110K *
Drive human factors and usability engineering while supporting regulatory submissions. Collaborate with cross-functional teams to enhance product safety and compliance in bringing innovative medical t...
2 days ago
Senior Specialist, QA Operations
$110K - $135K *
Drive quality assurance excellence by overseeing compliance, batch review, and documentation practices, while collaborating with cross-functional teams to enhance operational efficiency and product re...
1 week ago
Associate Principal Scientist, Global Regulatory Lead
$120K - $150K *
Lead global regulatory strategy for medical devices and combination products. Manage complex projects, liaise with regulatory agencies, and ensure compliance while supporting product development and p...
2 weeks ago
Senior Director, Clinical Regulatory Affairs
$253K - $312K *
Lead the charge in developing and executing cutting-edge regulatory strategies for innovative cancer therapies, shaping interactions with global health authorities, and ensuring successful drug submis...
Reposted 1 week ago
Senior Specialist, Quality Assurance
$106K - $167K *
Join us in ensuring the highest standards of quality for GMP computerized systems. Collaborate with diverse teams to oversee system lifecycle management, drive compliance, and enhance process improvem...
Yesterday
Postmarket Surveillance Specialist III
$77K - $86K *
Drive quality assurance initiatives by analyzing performance data to identify trends, potential risks, and support continuous improvement in a regulated environment, ensuring product reliability throu...
2 days ago
$90K - $130K *
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...
1 week ago
Specialist, Quality Engineering
$75K - $95K *
Design comprehensive quality improvement systems to enhance organizational compliance and operational excellence, ensuring customer commitments are met through effective collaboration across multiple...
5 days ago
$120K - $190K *
Join an innovative team as a Clinical Affairs Specialist, where you'll develop strategies, improve processes, and ensure compliance in a dynamic, supportive environment dedicated to advancing clinical...
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.