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 Affairs Associate - Generalist
$90K - $120K *
Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...
3 days ago
$92K - $138K *
Accelerate global regulatory advancements by managing complex projects, developing strategies for device submissions, and leading teams to ensure compliance in diverse markets while navigating evolvin...
4 weeks ago
$92K - $138K *
Drive global regulatory success by leading complex projects to secure and maintain approvals, develop comprehensive strategies, and navigate multifaceted regulations across new markets and device chan...
4 weeks ago
Senior Regulatory Affairs Consultant - Ad Promo
$120K - $150K *
Champion compliance and innovation by advising cross-functional teams on FDA advertising regulations, driving strategic decisions to mitigate risks while supporting business objectives in healthcare c...
2 weeks ago
Sr. Regulatory Affairs Specialist II
$90K - $120K *
Lead regulatory compliance efforts by guiding product development, managing submissions, and collaborating with cross-functional teams to ensure timely and accurate adherence to regulations across var...
4 weeks ago
Senior Director, Regulatory Affairs
$240K - $265K *
Join a team that's shaping global regulatory strategies for innovative therapies. Oversee regulatory submissions and mentor a talented team to ensure compliance and excellence in clinical development...
1 month ago
Regulatory Affairs Consultant - Clinical Regulatory Affairs
$90K - $130K *
Lead the charge in regulatory strategy for clinical studies, providing expert guidance on complex global compliance. Drive communication with health authorities and ensure timely documentation while c...
Reposted 1 week ago
Senior Associate, Regulatory Affairs (US)
$85K - $110K *
Take ownership of U.S. regulatory submissions, ensuring accuracy and compliance with FDA requirements. Collaborate cross-functionally to coordinate IND, NDA, and BLA filings, executing processes withi...
2 weeks ago
Director/Senior Director, Global Regulatory Affairs
$212K - $290K *
Champion regulatory excellence by leading global strategies for product approvals, collaborating with cross-functional teams and external experts to ensure compliance and drive successful commercializ...
2 weeks ago
Senior Regulatory Affairs Licensing Engineer (remote eligible)
$111K - $213K *
Lead regulatory initiatives and ensure compliance for nuclear projects, leveraging 5+ years of experience in licensing. Collaborate cross-functionally to drive complex projects and deliver effective d...
3 weeks ago
Associate Director, Regulatory Affairs
$146K - $196K *
Shape the future of regulatory strategy by leading projects that ensure compliance and market access. Drive collaboration across teams while managing processes for development and post-approval phases...
4 weeks ago
$65K - $101K *
Manage regulatory affairs for clinical research, ensuring compliance with FDA and GCP guidelines. Oversee study submissions, documentation, and collaborate with investigators to maintain quality and c...
2 weeks ago
Regulatory & Clinical Specialist
$85K - $95K *
Join a team that's shaping the future of active implantable medical devices by supporting clinical evaluations and regulatory submissions. Collaborate across disciplines to ensure compliance with EU a...
1 week ago
Senior Specialist, Quality Assurance - Drug Substance
$115K - $135K *
Join a team that's committed to executing quality assurance for drug substance manufacturing, ensuring compliance with cGMP standards while supporting cross-functional collaboration and continuous imp...
1 week ago
Regulatory Strategy, Director (Bay Area, Boston)
$150K *
Contribute to regulatory excellence by leading teams to develop successful strategies for biotech and pharmaceutical projects, ensuring compliance with FDA and global agencies while enhancing innovati...
Reposted 1 week ago
Senior Consultant - Regulatory Strategy
$89K - $148K *
Join us in leading regulatory strategy for utility clients, managing multiple complex projects, and delivering high-quality work while coaching a dynamic team. Your expertise will shape innovative sol...
3 weeks ago
Senior Associate, Regulatory Affairs, Promotional Operations
$93K - $123K *
Shape the future of regulatory promotional operations by driving standards and streamlining review processes of promotional materials. Collaborate cross-functionally to ensure compliance and efficacy...
4 weeks ago
Regulatory Affairs Operations Manager
$100K - $130K *
Lead our regulatory operations team in navigating UDI compliance and FDA regulations for medical devices, ensuring accurate registrations and supporting cross-functional initiatives that enhance produ...
6 days ago
$120K - $150K *
Transform regional regulatory engagement by leading strategy, fostering relationships, and advocating for efficient electric transmission policies. Collaborate across departments to align regulatory g...
2 weeks ago
Lead Regulatory Affairs Licensing Engineer (remote eligible)
$98K - $188K *
Transform regulatory practices by leading licensing projects and enhancing compliance frameworks. Collaborate with cross-functional teams to effectively manage commercial nuclear challenges and secure...
2 days ago
Senior Process Engineer- Small Molecule/ Oligo/ Peptide
$103K - $165K *
Support pharmaceutical and chemical projects by leading process design, scale-up, and optimization initiatives. Engage with clients and mentor junior engineers to deliver high-quality outputs aligning...
2 days ago
Clinical Quality Assurance Specialist (Fixed-Term)
$75K - $95K *
Join a dynamic team committed to ensuring compliance with regulatory standards while providing clinical support and training. Collaborate with clinicians and sales representatives to resolve product c...
1 week ago
Principal Specialist, Quality System Compliance Auditor (Remote)
$86K - $165K *
Join a team that drives compliance excellence through second-party QMS audits. Leverage your quality assurance expertise in aerospace and defense to identify opportunities for improvement across vario...
3 days ago
Regulatory Affairs CMC Senior Associate / Consultant - Biologics or Vaccines
$90K - $130K *
Engage with us to shape cutting-edge CMC regulatory strategies. Lead impactful submissions and lifecycle activities, collaborating across teams to enhance patient outcomes worldwide. Join a dynamic en...
2 weeks ago
Senior Clinical Research Associate
$90K - $120K *
Transform clinical research execution by leading study delivery at sites, ensuring adherence to regulations and collaborating effectively with local teams and investigators for superior study performa...
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.