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.
$66K - $125K *
Manage clinical monitoring and site management processes, ensuring compliance with protocols, ICH-GCP guidelines, and regulations. Conduct remote/on-site visits, facilitate communication, and support...
2 weeks ago
$144K - $180K *
Deliver impact by owning the build of a key Client Communications Service, refining the roadmap and enabling features to enhance client engagement and retention, ensuring alignment with compliance sta...
1 week ago
Senior Research Scientist - Real World Evidence
$100K - $125K *
Help us lead impactful Real World Evidence studies to enhance healthcare outcomes. You'll drive data analyses, collaborate cross-functionally, and act as a key analytics expert to ensure successful pr...
2 weeks ago
Manager, US Medical Ad/Promo Regulatory Review
$116K - $182K *
Lead regulatory strategies for US promotional materials, ensuring compliance with FDA standards while collaborating across departments. Provide expertise for complex products, navigating regulatory la...
1 week ago
Sr. Scientist I - Analytical Chemistry and Molecular Biology - FSP
$110K - $130K *
Transform the future of analytical chemistry by leading high-throughput testing, sample analysis, and documentation in a dynamic lab environment. Collaborate with a team to ensure compliance with safe...
3 days ago
Senior Cardiopulmonary Specialist - Remodulin/Orenitram
$155K - $180K *
Accelerate your career by promoting innovative therapies in cardiopulmonary health. Engage health professionals, drive sales strategies, and enhance patient education in a dynamic and supportive terri...
1 week ago
Senior Account Manager, Promotional Medical Education
$85K - $95K *
Drive project success by overseeing account operations, ensuring tactical alignment, and fostering strategic partnerships to enhance client satisfaction and team performance across high-profile initia...
Reposted 3 days ago
$100K - $130K *
Transform post-market surveillance documentation by leading the development and compliance of PSURs and PMSRs. Collaborate with cross-functional teams to ensure regulatory adherence and mentor junior...
3 days ago
Clinical Research Associate II, Phase I
$105K - $118K *
Lead the high-quality monitoring of clinical trials, ensuring compliance with regulatory standards while managing site operations, training staff, and protecting participant safety in a fast-paced, dy...
1 week ago
Senior Counsel, Regulatory Compliance
$132K - $220K *
Partner with us to navigate complex healthcare regulations and compliance. You'll advise on legal matters, support risk assessments, and enhance compliance programs, ensuring our operations meet ever...
1 week ago
Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated; NA/CAN/UK
$80K - $175K *
Oversee the development and execution of medical writing projects, ensuring accuracy and compliance with regulatory standards. Collaborate cross-functionally to deliver high-quality documents and ment...
1 week ago
Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated; NA/CAN/UK
$80K - $175K *
Champion the creation of high-quality regulatory documents, managing writing tasks and leading reviews. Collaborate across teams to ensure clarity and compliance, mentoring junior writers while delive...
1 week ago
Advisor/Sr. Advisor - CSQA Representative, Catalyze360 Quality
$129K - $211K *
Lead the charge in establishing digital quality strategies and embedding best practices within agile software delivery, ensuring compliance and performance across internal and external platforms while...
4 days ago
Field Application Specialist - Bioprocessing - Fluid Management Technology (Single Use) - Southeast
$90K - $110K *
Accelerate innovative therapies by providing technical expertise, supporting sales, and ensuring seamless product adoption with customers in fluid management technology across the US region...
1 week ago
Field Specialist- Mechanical Sales
$80K - $95K *
Unlock your potential as a resourceful sales expert driving mechanical construction growth. Cultivate invaluable relationships, educate clients, and elevate our market presence through innovative solu...
6 days ago
Field Specialist- Mechanical Sales
$80K - $95K *
Join a skilled team dedicated to driving growth in the mechanical construction sector. As a key player, you'll leverage technical expertise and market insight to build lasting relationships and expand...
6 days ago
Senior Director, Pharmacovigilance
$230K - $325K *
Lead strategic pharmacovigilance initiatives, ensuring compliance and operational excellence for global drug safety, signal management, and regulatory submissions, while preparing for Phase 3 developm...
3 weeks ago
$77K - $114K *
Drive scalable import operations by ensuring compliance through analytics, tariff classifications, and cross-functional collaborations. Advance trade initiatives while leading projects to enhance regu...
1 week ago
Senior Clinical Specialist, AI Systems
$130K - $160K *
Transform clinical outcomes by bridging the gap between product, engineering, and clinical teams, ensuring our AI systems deliver safe and clinically meaningful information to members through rigorous...
4 weeks ago
Associate Director, Commercial Manufacturing & Packaging
$150K - $195K *
Lead the strategy and execution of commercial drug product manufacturing, ensuring operational performance and supply security while collaborating across teams to develop effective manufacturing plans...
5 days ago
Site Contracts Specialist II or Sr. Site Contracts Specialist
$56K - $115K *
Join a dynamic team as a Site Contracts Specialist, where you will negotiate and manage clinical trial agreements. Lead contract discussions, mitigate risks, and collaborate with key stakeholders to e...
1 week ago
$110K - $130K *
Deliver high-quality regulatory writing for Phase 1-3 clinical trials, ensuring operational excellence and compliance. Collaborate with teams to create, review, and mentor on complex documents that su...
4 weeks ago
Senior Software Engineer-Decision Logic & Regulatory Workflow
$80K - $128K *
Lead the charge in developing advanced software solutions to enhance federal regulatory workflows for endangered species compliance, integrating complex decision logic and ensuring streamlined functio...
2 weeks ago
Site Contracts Specialist II or Sr. Site Contracts Specialist
$56K - $115K *
Unlock potential by leading the negotiation and management of clinical trial contracts. Collaborate with diverse stakeholders to ensure compliance and facilitate impactful clinical research initiative...
1 week ago
$95K - $110K *
Transform the contract lifecycle process by drafting, negotiating, and administering agreements. Collaborate with stakeholders to ensure compliance and clarity in all contractual engagements, while su...
Reposted 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.