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 Engineer I, Device Development
$97K - $146K *
Drive the development of innovative combination products as a Development Engineer, collaborating cross-functionally to ensure design integrity, safety, and compliance during the product lifecycle fro...
Yesterday
Senior Engineer I, Device Development
$97K - $146K *
Lead the development of innovative medical devices, driving cross-functional collaboration while managing technical design and ensuring compliance through a structured development process. Your expert...
Yesterday
Senior Regulatory Medical Writer, Client-embedded, FSP
$105K - $125K *
Unlock your potential as a Senior Medical Writer, leading the creation of critical regulatory documents, collaborating cross-functionally, and ensuring compliance with industry standards while mentori...
1 week ago
Quality Assurance Area Specialist III - Finished Production
$75K - $95K *
Join a team that's committed to ensuring compliance and quality in production. You will oversee batch release processes, manage quality documentation, and coach on best practices, ensuring unwavering...
1 month ago
Senior Manager, US Licensure and UDI
$122K - $212K *
Lead quality management for UDI processes and US licensure, ensuring compliance and operational excellence through cross-functional collaboration. Drive global process improvement and governance to en...
3 days ago
Director/Sr. Director Regulatory CMC, Lilly Regenerative Medicine
$163K - $281K *
Elevate your career by leading regulatory CMC strategies for innovative gene therapies, ensuring compliance and driving successful submissions throughout the product lifecycle in a dynamic, cross-func...
3 days ago
Director/Sr. Director Regulatory CMC, Lilly Regenerative Medicine
$163K - $281K *
Shape the future of gene therapy by leading regulatory CMC strategies for innovative therapies. Collaborate with cross-functional teams, ensure compliance, and guide projects from development to comme...
3 days ago
Senior Specialist (Manager), Order Management Systems and Processes
$111K - $185K *
Explore new horizons with a key role enhancing order-to-cash processes. Drive operational excellence and system improvements for user experience while managing cross-functional collaboration and deliv...
3 weeks ago
$95K - $210K *
Oversee the creation of regulatory documents for global submissions while mentoring junior writers. Drive cross-functional collaboration and ensure compliance with clinical and regulatory standards in...
Yesterday
$95K - $210K *
Accelerate progress at developing essential regulatory documents for clinical submissions globally, leading cross-functional teams and mentoring writers to ensure high-quality delivery in alignment wi...
1 week ago
Senior Regulatory Medical Writer, Client-embedded, FSP
$105K - $125K *
Elevate the impact of medical writing by authoring critical regulatory documents, collaborating with diverse teams, and mentoring junior writers. Drive operational excellence and contribute to the pha...
3 weeks ago
Sr. Engineer, Quality Assurance
$100K - $130K *
Unlock quality excellence in analytical testing! Lead improvements and ensure compliance across systems, while fostering a quality-focused culture in a collaborative lab environment. Drive efficiency...
4 days ago
$178K - $257K *
Champion the development and execution of global regulatory strategies, leading cross-functional teams to ensure product approval and compliance while fostering team performance and navigating complex...
Reposted 2 weeks ago
$178K - $257K *
Lead the charge in developing innovative global regulatory strategies, ensuring alignment across teams and functions. Drive performance within the Global Regulatory Team while navigating the complexit...
Reposted 2 weeks ago
Associate Principal Scientist, Sterile Drug Product Commercialization
$142K - $224K *
Elevate your career as a Lab Excellence Lead, driving lab operations, safety, and compliance while supporting drug product tech transfer and process development for the commercialization of biologics...
Yesterday
Senior Mechanical Engineer, Research & Early Development
$87K - $162K *
Drive innovation in next-generation sequencing by solving complex mechanical challenges. Collaborate with cross-functional teams to design, develop, and integrate advanced electro-mechanical systems t...
2 weeks ago
Senior Research Budget Specialist - Ex-US
$90K - $120K *
Join a dynamic team to manage global clinical trial budgeting and contracts, ensuring smooth startup and financial performance across international sites while collaborating with various operational a...
1 week ago
Senior Corporate Compliance Manager - Monitoring
$120K - $150K *
Lead compliance oversight and monitoring initiatives, manage audits, and support investigations in the life sciences space. Ensure regulatory adherence while collaborating across teams to enhance comp...
2 weeks ago
Consultant, Regulatory Affairs
$90K - $120K *
Join a team that drives digital inclusion and innovates within the telecommunications sector. Lead client relationships and regulatory compliance efforts while mentoring junior staff to ensure excepti...
Reposted 1 week ago
Principal Business Analyst - Therapeutic Focus Areas
$114K - $187K *
Pioneer effective data solutions by analyzing scientific processes, translating business goals into actionable requirements, and collaborating with cross-functional teams to enhance data integrity in...
2 days ago
Regulatory Affairs Director - Hybrid (Bronx Office)
$135K - $237K *
Champion regulatory excellence in a dynamic environment, driving compliance and oversight through effective leadership. Foster relationships, manage audits, and guide the team in enhancing organizatio...
Reposted 4 days ago
$83K - $138K *
Elevate compliance and quality alongside operations by mentoring teams on CAPA processes, driving continuous improvement, and leading investigations in a dynamic, regulated setting while ensuring adhe...
Yesterday
Document Control, Senior Specialist
$111K - $185K *
Drive the effectiveness of a corporate document control program, supporting quality compliance and integrity of documentation. Collaborate with teams to oversee document lifecycle processes and mainta...
2 weeks ago
$85K - $110K *
Elevate your career by leading innovative QC projects, collaborating with teams, conducting advanced analytical testing, and ensuring compliance while training fellow scientists in a supportive, fast...
3 weeks ago
$82K - $118K *
Transform bioprocess development in a collaborative environment, addressing challenges while ensuring compliance and safety. Leverage extensive lab experience to execute upstream and downstream proces...
5 days 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.