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.
$75K - $95K *
Optimize manufacturing processes and support project initiatives while leading equipment changes, documentation efforts, and continuous improvement in a regulated GMP environment with a focus on innov...
3 weeks ago
Senior Technical Regulatory Compliance Engineering Specialist
$147K - $221K *
Lead the charge in ensuring regulatory compliance and safety for product development. Collaborate with cross-functional teams to solve complex engineering challenges while advocating for international...
Yesterday
Senior Government Affairs Specialist
$79K - $109K *
Research and implement advocacy strategies, monitor legislation, and manage PAC activities. Collaborate with teams to ensure compliance and support federal and state-level initiatives, contributing to...
3 weeks ago
Senior Government Affairs Specialist
$79K - $109K *
Partner with us to shape impactful advocacy strategies on state legislation and manage political action initiatives, ensuring compliance while collaborating across teams to navigate funding opportunit...
3 weeks ago
Quality Assurance Specialist (BT-26127)
$105K - $150K *
Lead quality assurance inspections for space flight hardware, ensuring compliance with customer and industry standards. Collaborate on quality plans and rectify inspection discrepancies while maintain...
Reposted 1 week ago
Quality Assurance Specialist (BT-26127)
$105K - $150K *
Join a team that ensures quality assurance for space flight hardware, executing inspection functions and compliance. Collaborate with engineers to uphold standards while maintaining certifications and...
Reposted 1 week ago
Senior Technical Services Engineer
$75K - $95K *
Reimagine pharmaceutical manufacturing through expert technical support and process optimization. Collaborate across teams to ensure compliance, enhance productivity, and lead scale-up projects while...
4 days ago
Senior Specifications Specialist
$80K - $100K *
Advance your career by leading specification initiatives, collaborating with project teams, and supporting technical standards across Western Canada while enhancing project outcomes through innovative...
2 weeks ago
Senior Associate, Regulatory CMC
$90K - $120K *
Join a team that's redefining biotech innovation by enhancing Regulatory CMC strategies for biological and cell therapy products, ensuring compliance and successful submissions while fostering collabo...
Today
$101K - $169K *
Join a team that's enhancing supplier quality through process audits, continuous improvement, and strategic supplier development in electronics manufacturing, impacting product lifecycle from design t...
4 days ago
Process Specialist, Supplier Quality Assurance
$70K - $95K *
Lead disciplined execution of supplier quality processes, driving accountability, performance improvements, and timely resolution of quality issues. Collaborate with stakeholders to ensure alignment a...
2 weeks ago
Senior Specialist, Clinical Supply Chain
$120K - $150K *
Drive the management of global clinical supply chain operations across studies. Ideal for a proactive individual skilled in planning and logistics, ensuring effective execution and vendor coordination...
6 days ago
Senior Specialist, Restricted Substances
$100K - $130K *
Unlock potential by guiding regulatory compliance for restricted substances across global markets, ensuring adherence to pivotal regulations while leading teams in chemical management projects to supp...
1 week ago
Senior Procurement Specialist - Compliance
$80K - $120K *
Elevate compliance standards by overseeing procurement reviews, ensuring adherence to policies, and collaborating with key stakeholders to develop effective systems that mitigate risk and enhance oper...
1 week ago
Sr. Director, Strategic Regulatory Affairs and UDI
$203K - $253K *
Drive global regulatory excellence by leading teams in strategic operations, UDI, and compliance. Partner cross-functionally to ensure market access and develop robust governance frameworks, while fos...
3 weeks ago
Regulatory Specialist - Quality & Patient Safety - Full-Time
$92K - $152K *
Elevate hospital compliance as a Regulatory Specialist, driving accreditation readiness across NewYork-Presbyterian. Collaborate with teams, analyze data, and implement corrective plans to ensure adhe...
Reposted today
Quality Engineer - Design Quality Assurance & Sterilization
$80K - $110K *
Transform quality assurance practices to ensure regulatory compliance in new product development and global sterilization. Collaborate across teams to uphold standards, lead risk assessments, and driv...
2 days ago
PHARMACEUTICAL - SR. CQV ENGINEER
$100K - $115K *
Collaborate with a dynamic team to lead the commissioning and qualification of bioprocess systems in the pharma/biotech industry. Shape project success by managing teams and ensuring compliance with r...
1 week ago
PHARMACEUTICAL - SR. CQV ENGINEER
$100K - $115K *
Champion the validation of biopharma systems, leading teams to ensure compliance and excellence in commissioning, qualification, and project management while fostering a collaborative team environment...
3 weeks ago
Sr Regulatory Analyst (Beauty and Personal Care)
$96K - $118K *
Drive product compliance and safety by collaborating globally on regulatory issues, guiding product development, and analyzing ingredients, while supporting teams in ensuring adherence to evolving reg...
2 weeks ago
Senior Quality Engineer (Remote - United States)
$106K - $145K *
Help us ensure quality for medical devices by leading investigations and compliance initiatives while collaborating with diverse teams to drive continuous improvement and maintain high standards in pr...
3 weeks ago
Associate Director, Regulatory Affairs Labeling Product Leader
$137K - $235K *
Engineer innovative labeling strategies that drive project success and collaboration in regulatory affairs. Lead cross-functional teams to align on labeling content, ensuring compliance and scientific...
3 weeks ago
Associate Director, Regulatory Affairs Labeling Product Leader
$137K - $235K *
Lead global labeling strategy by collaborating with cross-functional teams to ensure compliance and alignment with regulatory requirements. Drive target labeling development leveraging competitor insi...
3 weeks ago
Associate Director, Regulatory Affairs Labeling Product Leader
$137K - $235K *
Take ownership of global labeling strategy, collaborating with cross-functional teams to develop and maintain high-quality label content. Drive innovative solutions in regulatory affairs while ensurin...
3 weeks ago
Associate Director, Regulatory Affairs Labeling Product Leader
$137K - $235K *
Innovate global labeling strategies for pharmaceutical products. Lead teams to align regulations, develop target labels, and enhance compliance processes. Foster collaboration across functions to ensu...
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.