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.
$80K - $95K *
Champion regulatory compliance programs by managing licensure, operational support, and intelligence assessment within pharmaceutical distribution, ensuring accurate documentation and adherence to ind...
Yesterday
Senior Specialist Regulatory Affairs
$95K - $159K *
Reimagine global regulatory strategies and submissions, ensuring compliance across various markets. Collaborate with cross-functional teams to navigate complexities in product lifecycle and meet regul...
2 weeks ago
Regulatory Affairs Specialist II
$80K - $100K *
Help us shape the future of regulatory compliance by supporting submissions, approvals, and post-launch activities. Engage with cross-functional teams to ensure adherence to guidelines while managing...
1 week ago
Principal Regulatory Affairs Specialist
$110K - $130K *
Transform regulatory compliance by leading submissions and strategies for high-risk medical devices. Collaborate with cross-functional teams to ensure adherence to FDA and Health Canada standards thro...
3 weeks ago
Senior Specialist, Regulatory Affairs
$83K - $138K *
Join a team that fosters regulatory excellence throughout product life cycles, ensuring compliance with global standards. Collaborate cross-functionally, contribute to regulatory strategies, and drive...
Reposted 1 week ago
Sr Regulatory Affairs Specialist
$91K - $152K *
Lead the charge in regulatory efforts for software solutions, ensuring compliance with FDA and international standards while collaborating with cross-functional teams to drive innovation and streamlin...
6 days ago
Senior Specialist, Regulatory Affairs
$95K - $115K *
Unlock potential by leading regulatory strategies for medical devices, ensuring compliance and efficient approvals while mentoring others. Engage with cross-functional teams to design documentation an...
3 weeks ago
Senior Regulatory Affairs Specialist (OTTAVA)
$92K - $148K *
Shape regulatory strategies for innovative surgical technologies. Collaborate with engineering and clinical teams to ensure compliance and facilitate global market access through successful FDA and in...
Yesterday
Senior Regulatory Affairs Specialist (OTTAVA)
$92K - $148K *
Drive innovation in regulatory strategy to enhance robotic surgical solutions. Collaborate with engineering and clinical teams while ensuring compliance and successful submissions for global product a...
2 weeks ago
Senior Regulatory Affairs Specialist (OTTAVA)
$106K - $170K *
Shape the future of medical technology by joining our Regulatory Affairs team. Collaborate closely with engineering and clinical partners to ensure global compliance and streamline regulatory submissi...
2 weeks ago
Senior Regulatory Affairs Specialist - Clinical
$87K - $149K *
Invent innovative clinical regulatory strategies for next-gen diabetes devices, collaborating globally across various teams to navigate complex regulations and ensure successful product submissions in...
1 week ago
Senior Clinical Research Quality and Compliance Specialist
$161K - $218K *
Elevate compliance and risk management in FDA-regulated clinical research through expert leadership and quality oversight across clinical trials, ensuring effective protocols and inspection readiness...
1 week ago
Senior Regulatory Affairs Specialist - Heart Failure (on-site)
$90K - $180K *
Lead the charge in regulatory approval processes, ensuring compliance globally while collaborating cross-functionally to present product registration documentation effectively and efficiently...
Reposted 2 weeks ago
Principal Specialist, Regulatory Affairs
$110K - $130K *
Drive regulatory strategies for medical device approvals globally, ensuring compliance. Collaborate across teams to prepare submissions and lead initiatives that enhance operational efficiency while m...
2 days ago
Regulatory Affairs Specialist (Boston, MA)
$80K - $95K *
Join a dynamic team to ensure compliance and regulatory excellence in documentation and submissions. Collaborate on vital regulatory affairs projects while engaging with key regulatory agencies to fac...
3 weeks ago
Senior Manager, Regulatory Affairs
$110K - $130K *
Advance your career by leading regulatory strategies and submissions for biologics. This role collaborates with cross-functional teams to ensure compliance and effectively communicates with agencies t...
Reposted 2 days ago
Senior Regulatory Affairs Specialist
$99K - $129K *
Lead the charge in global regulatory strategies for innovative medical devices, driving project success from registration to compliance. Collaborate across teams to enhance healthcare technologies and...
3 weeks ago
Sr. Specialist, Regulatory Strategy
$103K - $141K *
Explore your career in regulatory submissions, ensuring compliance and alignment with local and regional requirements. Play a key role in the coordination of critical filings, supporting product appro...
Yesterday
Sr. Specialist, Regulatory Strategy
$103K - $141K *
Unlock potential by coordinating regulatory submissions for product approvals, ensuring compliance with regulations and company policies. Drive project timelines, participate in internal strategies, a...
2 weeks ago
Regulatory Affairs Specialist II - Labeling & Promotion
$80K - $95K *
Join a team that's pivotal in regulatory strategy, independently preparing eCTD submissions, and assessing promotional materials for compliance while collaborating with cross-functional teams to ensur...
4 weeks ago
$80K - $95K *
Champion process excellence in Regulatory Affairs by managing issue resolution and enhancing compliance operations. Collaborate cross-functionally to ensure inspection readiness and support effective...
1 week ago
Regulatory Affairs Specialist (Innovation)
$95K - $153K *
Shape the future of diagnostic innovation by guiding new product development through regulatory strategies, risk assessments, and FDA submissions while collaborating with diverse teams across scientif...
1 week ago
Sr. Regulatory Affairs Specialist
$97K - $122K *
Deliver comprehensive regulatory submissions and ensure compliance with FDA and global standards. Contribute expertise in the medical device field while collaborating with cross-functional teams on in...
4 weeks ago
Regulatory Affairs Specialist (Innovation)
$95K - $153K *
Transform innovation in regulatory affairs by guiding development teams on compliance strategies for diagnostic devices and software. Lead submissions and risk assessments, ensuring thorough collabora...
1 week ago
Sr. Staff Regulatory Affairs Specialist
$135K - $145K *
Elevate your career by mentoring a dynamic Regulatory Affairs team while driving compliance and strategic regulatory initiatives in the medical device industry. Make a substantial impact in global reg...
4 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.