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.
Quality Engineer - AS9102 FAI Specialist for Middletown, Connecticut
$82K - $92K *
Lead quality inspections in aerospace, focusing on AS9102 FAI compliance while collaborating with engineers to ensure accuracy in reporting and adherence to specifications for parts and assemblies. Dr...
4 weeks ago
$135K - $145K *
Join a team that drives quality excellence and regulatory compliance through leadership in quality engineering. Influence teams, mentor talent, and lead initiatives for continuous improvement within a...
3 weeks ago
Senior Manager of Validation Engineering
$110K - $130K *
Lead the Validation team in implementing critical qualification procedures for sterile injectables. Collaborate with various stakeholders to ensure compliance and optimal performance in manufacturing...
2 weeks ago
$95K - $115K *
Collaborate with cross-functional teams to drive proposal development and ensure timely, compliant, and accurate quotes for customer opportunities. Lead proposal initiatives, manage timelines, and com...
Yesterday
Senior Product Manager, Regology
$150K - $180K *
Lead the charge in shaping a high-impact regulatory compliance product, driving cross-functional collaboration and strategic outcomes. Elevate team performance and ensure customer value through data-i...
3 weeks ago
Senior Specialist, QA Material Disposition
$70K - $107K *
Join a team that's pivotal in enhancing quality assurance for biopharmaceuticals. This role leads investigations and ensures compliance in material disposition, while supporting regulatory readiness a...
2 weeks ago
Quality Engineer 2, Design Assurance
$80K - $95K *
Transform product development by ensuring design quality and compliance from concept to launch. Collaborate across functions to manage design controls, risk management, and verification for innovative...
1 week ago
$116K - $160K *
Join us to support global regulatory activities throughout product lifecycles, collaborating cross-functionally for high-quality submissions and interactions with health authorities. Bring your expert...
1 week ago
Senior Director, North American Compliance
$231K - $301K *
Lead the charge in compliance strategy for U.S. Commercial and Market Access. Collaborate with senior leaders to guide complex compliance issues, manage risks, and support innovative business objectiv...
Yesterday
Manager, Regulatory Affairs Operations
$125K - $160K *
Take ownership of global regulatory submissions, ensuring timely, compliant delivery of documents for FDA and other health authorities. Collaborate across teams to enhance submission quality and manag...
Reposted 2 days ago
Sr. Director, Sterility Assurance - Global Quality Technical Operations
$150K - $180K *
Shape the future of sterility assurance by developing global standards, leading contamination control strategies, and establishing a Center of Excellence to ensure compliance and foster innovation acr...
Reposted 4 weeks ago
Senior Manager Product Stewardship & Regulatory Affairs
$100K - $140K *
Shape the future of global regulatory compliance and digital transformation by leading innovative AI-driven strategies and operationalizing regulatory intelligence across product lifecycles and intern...
Yesterday
$95K - $115K *
Manage cross-functional teams to enhance product quality and compliance. Pioneer defect management processes and spearhead quality improvement initiatives. Lead safety assessments, ensuring alignment...
1 week ago
$96K - $120K *
Unlock potential by supporting laboratory operations, technical training, and equipment maintenance to ensure optimal assay activities. Partner with teams on audits, project execution, and continuous...
3 days ago
Senior Logistics Compliance Analyst
$95K - $115K *
Optimize international trade compliance by driving import/export strategies, ensuring adherence to regulations, and supporting logistics operations, while fostering collaboration across teams to navig...
2 days ago
Quality Assurance Operations Lead
$80K - $95K *
Accelerate quality assurance initiatives by developing systems that ensure compliance with FDA and cGMP standards while collaborating with cross-functional teams to enhance manufacturing processes wit...
Yesterday
$100K - $120K *
Lead the charge in the inspection operations of a dynamic biopharma company. Drive strategic initiatives, ensure compliance, and develop talent while managing multiple shifts in a fast-paced, quality...
4 weeks ago
Senior Director, Regulatory Clinical Strategy
$203K - $267K *
Lead regulatory strategy for complex clinical projects, ensuring cohesive integration across global platforms while mentoring teams and managing both internal resources and vendor relationships for op...
Reposted 2 weeks ago
$80K - $95K *
Champion inventory excellence by overseeing purchasing activities and strategies. Collaborate closely with Operations and Finance teams to ensure seamless supply management and exceptional vendor rela...
3 weeks ago
Senior Managing Counsel, MedSurg Commercial and Government Contracting (Remote - United States)
$187K - $257K *
Elevate legal strategies by leading commercial contracting initiatives across U.S. and Canada for MedSurg operations. Collaborate with business leaders to navigate complex agreements while ensuring co...
3 weeks ago
Pharmaceutical Development Lead Scientist I
$95K - $115K *
Elevate your career as a technical leader in pharmaceutical formulation development. Drive innovation, oversee clinical trial manufacturing, and ensure compliance, while mentoring and managing a team...
3 weeks ago
Experienced Quality Systems Specialist
$79K - $112K *
Elevate operational efficiency by aligning business processes with stakeholder needs. Act as a vital link across teams to drive planning, issue resolution, and continuous improvement initiatives, ensu...
4 days ago
Configuration Management Specialist - Management Analyst III
$95K - $115K *
Contribute to the success of the Artemis Program by implementing robust configuration management strategies ensuring compliance and efficiency in documentation and process improvement for flight and g...
3 days ago
Senior Associate Regulatory and Business Continuity
$102K - $125K *
Join a collaborative team to ensure regulatory compliance and business continuity, conducting assessments and submissions in line with FDA guidelines while managing cross-functional projects and datab...
3 weeks ago
Design Verification Engineer (Lab Project Specialist)
$85K - $115K *
Join us to lead verification strategies for medical device products, collaborating across R&D, quality, and regulatory teams. Leverage your expertise in design verification and testing to ensure compl...
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.