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.
AD/Director, Regulatory Affairs CMC
$190K - $285K *
Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...
Reposted 2 days ago
$83K - $111K *
Engage customers by leveraging technical sales expertise in scientific instruments. Collaborate with cross-functional teams to meet customer needs and enhance solutions that drive revenue growth and s...
3 weeks ago
Senior Supervisor, Post-Market Surveillance & Clinical Follow-up
$78K - $121K *
Lead the charge in global post-market surveillance by overseeing deliverables, providing team leadership, and ensuring regulatory compliance for medical devices. Engage in strategy, analysis, and cros...
3 weeks ago
Senior Manager, Global Regulatory Strategy
$125K - $150K *
Join a dedicated team driving global regulatory strategy for early-stage oncology products. You'll execute and manage high-quality submissions and collaborate across functions to ensure compliance and...
1 week ago
Senior Director, Regulatory Affairs - Early Development/Business Development
$222K - $303K *
Drive regulatory leadership for early-stage drug development with cross-functional collaboration, supporting strategic business decisions and ensuring strong regulatory alignment throughout product li...
Reposted 4 weeks ago
Senior Manager, Global R&D Audits & Inspections Readiness
$147K - $192K *
Lead the charge in ensuring continuous regulatory compliance and inspection readiness for R&D technology solutions by executing audit readiness strategies, embedding GxP compliance, and collaborating...
1 week ago
Senior Consultant - Regulatory
$110K - $130K *
Shape client success by leading complex consulting projects, integrating diverse workstreams into actionable insights, and driving high-quality deliverables while fostering team growth and managing st...
3 days ago
Director, Global Regulatory Affairs
$150K - $180K *
Join a team that drives regulatory excellence for clinical development, ensuring strategic and compliant submissions. Collaborate cross-functionally to accelerate drug approval processes while oversee...
3 weeks ago
Associate Director, Regulatory Labeling Strategy
$150K - $195K *
Partner with us to lead global regulatory labeling strategies, ensuring compliance and accuracy. Collaborate with cross-functional teams throughout the product lifecycle, shaping compelling and compli...
2 weeks ago
Manager Research Regulatory Affairs
$110K - $130K *
Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...
1 week ago
Senior BIM Specialist 2 - Nuclear
$100K - $152K *
Empower project delivery by leading BIM execution across multi-discipline teams. Drive model coordination, quality assurance, and collaboration efforts to ensure project standards and client requireme...
4 days ago
Principal Specialist, Supplier Quality & Development - Electronics (Remote)
$86K - $165K *
Empower our supply chain excellence by managing supplier quality, driving systemic improvements, and ensuring compliance. Collaborate across functions to boost performance and sustainability while lev...
Reposted 2 weeks ago
Senior Central Monitor (Remote)
$90K - $110K *
Accelerate clinical trial success by optimizing monitoring strategies and processes for efficient, quality data management in alignment with regulatory standards and timelines...
2 weeks ago
Regulatory Affairs & Entity Corporate Governance Manager
$100K - $120K *
Transform global entity management by coordinating across Finance, HR, and Legal. Ensure compliance, maintain corporate records, and build scalable processes as we expand internationally. Drive operat...
3 days ago
$150K - $180K *
Elevate sterility assurance and contamination control strategies globally. Lead risk assessments and foster best practices across our sterile manufacturing sites while championing continuous improveme...
Reposted 1 week ago
Senior Vice President, Head of Global Regulatory Affairs
$210K - $250K *
Join a team that's shaping the future of global regulatory strategy. Your expertise will drive compliance, oversee submissions, and lead a dynamic regulatory team in executing key strategies for produ...
1 week ago
Sr. Manager of Research Regulatory Affairs
$110K - $130K *
Take ownership of regulatory affairs operations, leading teams to enhance processes within clinical trials while ensuring compliance with regulations and fostering collaboration across departments...
3 weeks ago
$150K - $279K *
Empower government sector success by identifying sales opportunities and leveraging legal tech expertise. Join a dynamic team to boost revenue through strategic outreach and relationship building whil...
1 week ago
Principal Solution Sales Specialist - Bioprocessing Solutions
$153K - $173K *
Deliver end-to-end bioprocess solutions by leveraging deep expertise in biopharmaceutical workflows, guiding complex customer collaborations, and driving high-impact project leadership for long-term s...
Reposted 2 weeks ago
Senior Component Qualification Engineer 1 - Nuclear
$84K - $129K *
Join a team that's advancing nuclear engineering through component qualification, structural analysis, and seismic qualification for new and existing facilities. Collaborate with multidisciplinary exp...
3 weeks ago
Senior Air Permitting Specialist
$84K - $129K *
Support industry-leading projects in air permitting and environmental compliance. Collaborate with multi-disciplined teams to develop strategies for regulatory requirements, ensuring compliance throug...
Today
Associate Director, Global Regulatory Strategy
$150K - $180K *
Manage global regulatory strategies for clinical and commercial product registrations. Ensure compliance and successful market access for the PSMA franchise. Lead cross-functional collaborations and d...
3 weeks ago
$80K - $100K *
Contribute to regulatory compliance initiatives by managing complex analyses, addressing operational risks, and collaborating across departments to improve governance and support the organization’s st...
2 weeks ago
Sr Manager, Global Regulatory Affairs (AI/ML)
$150K - $180K *
Unlock potential by guiding global regulatory strategies for innovative AI/ML healthcare solutions. Collaborate cross-functionally to navigate complex regulations while balancing innovation and patien...
Reposted 3 days ago
$110K - $130K *
Accelerate the future of GMP cell therapy by leading CQV initiatives for facilities, equipment, and systems. Own qualification strategies and ensure compliant, risk-based validation aligned with indus...
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.