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 Regulatory Submissions Lead
$145K *
Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...
2 days ago
Associate Director, Promotional Regulatory Affairs
$150K - $225K *
Join a dynamic team to lead regulatory strategies, ensuring compliant promotional practices in pharma. Collaborate cross-functionally to guide materials review processes and implement innovative tacti...
Reposted 2 weeks ago
$120K - $145K *
Help us drive regulatory strategy and compliance at a leading energy company. Oversee filings, advocate company positions, manage procurement, and lead a skilled team to ensure operational success and...
Reposted 3 weeks ago
Associate Director, CMC Regulatory
$190K - $230K *
Shape the future of cell therapy by providing essential CMC regulatory expertise across the product lifecycle, collaborating with multidisciplinary teams to drive submissions and maintaining complianc...
2 weeks ago
$110K - $130K *
Lead validation initiatives for sterile manufacturing systems, ensuring compliance and efficiency. Collaborate with cross-functional teams to enhance operations and mentor peers. Drive continuous impr...
3 days ago
Associate Director Advertising and Promotion, Global Regulatory Affairs
$152K - $209K *
Empower your career by providing strategic regulatory guidance for promotional and medical communications, collaborating with diverse teams to ensure compliance and support business objectives in a fa...
3 weeks ago
Sr. Director, Global Regulatory Strategy, Oncology
$196K - $353K *
Transform regulatory strategies in oncology by leading global submissions, engaging with health agencies, and ensuring compliance with evolving regulations to secure market approvals for innovative mR...
4 days ago
Sr. Director, Global Regulatory Strategy, Oncology
$196K - $353K *
Drive strategic regulatory initiatives and ensure global compliance for oncology programs, navigating complex agency interactions, and securing market approvals for innovative mRNA therapeutics. Lead...
5 days ago
QA RA Director Consulting Position
$130K - $160K *
Shape the future of GMP readiness by developing strategic quality systems and roadmaps, ensuring efficient market entry for innovative cell-based assay products. Guide teams in compliance, regulatory...
3 weeks ago
Quality Assurance Senior Specialist
$95K - $115K *
Elevate your career by managing quality assurance in a GMP setting. Oversee supplier quality, lead audits, and ensure compliance with regulatory standards while driving continuous improvement across q...
3 days ago
Associate, Regulatory Affairs- Labeling
$94K - $105K *
Manage the preparation and review of regulatory labeling submissions, ensuring compliance with FDA standards while coordinating artwork and drug listings for commercial products and maintaining docume...
2 weeks ago
QA Manager, Aseptic Manufacturing Oversight
$117K - $137K *
Oversee quality compliance and aseptic operations, managing staff and processes to ensure regulatory adherence, risk assessment, and continuous improvement in a GMP environment...
4 weeks ago
Sr. Specialist, Financial Audit (Hybrid - Rahway, NJ)
$106K - $167K *
Join a dynamic team to execute financial and operational audits, ensuring robust controls and collaborating with clients to enhance audit effectiveness and integrity...
Reposted today
Director, Regulatory Affairs, Strategy
$150K - $180K *
Unlock regulatory excellence by leading global strategy for pivotal development programs, collaborating closely with cross-functional teams to navigate complex submissions and health authority interac...
Reposted 2 weeks ago
Senior Director, Regulatory Affairs Strategy - Cell Therapy
$218K - $327K *
Lead global regulatory strategy for high-complexity cell therapies, ensuring competitive pathways to approval. Collaborate with cross-functional teams and influence health authority dialogue for patie...
5 days ago
Senior Director, Regulatory Affairs Strategy - Cell Therapy
$218K - $327K *
Unlock potential by shaping global regulatory strategies for cell therapies, guiding complex programs from development through approval, and driving stakeholder engagement to enhance patient access an...
5 days ago
$77K - $129K *
Drive quality assurance by supporting manufacturing operations and process validation. Collaborate cross-functionally to enhance product quality within a highly visible medical device value stream, en...
Today
Senior Process Engineer - Equipment
$94K - $128K *
Lead engineering initiatives to enhance equipment reliability and efficiency in biopharma manufacturing. Collaborate cross-functionally to optimize processes and ensure compliance while mentoring team...
2 weeks ago
Regulatory Affairs Project Manager
$84K - $157K *
Develop regulatory strategies for innovative medical diagnostics, collaborating with teams across APAC, LATAM, Middle East, and Africa to enhance product compliance and approval processes. Drive impro...
3 days ago
Regulatory Affairs Project Manager
$84K - $157K *
Drive compliance and innovation in global regulatory affairs for medical diagnostics, ensuring adherence to international standards while supporting product approvals across diverse markets in APAC, L...
3 days ago
$90K - $110K *
Join our team to elevate quality engineering practices across product development and manufacturing. Drive compliance and ensure robust risk management while implementing innovative solutions for test...
1 week ago
$88K - $105K *
Drive the development and modification of innovative 3D CAD models for new products, collaborating across teams to optimize designs and ensure manufacturability while adhering to standards and custome...
2 weeks ago
Global Operational Quality Specialist
$110K - $130K *
Contribute to global quality excellence by overseeing QA/QC processes, ensuring compliance, and driving harmonization across sites while collaborating with cross-functional teams to optimize performan...
1 week ago
Assistant Director Clinical Regulatory Operations
$136K - $184K *
Empower regulatory excellence by leading strategic compliance operations, enhancing member experience and operational efficiency while ensuring adherence to evolving CMS and NCQA standards across mult...
3 weeks ago
Assistant Director Clinical Regulatory Operations
$136K - $184K *
Oversee a dynamic Clinical Regulatory Operations team, driving compliance and operational excellence across health services while partnering with stakeholders to enhance member care. Lead innovative s...
3 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.