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 Manager, Commercial Regulatory Operations
$194K - $227K *
Lead the review and approval process for promotional materials, ensuring compliant execution across teams. Drive operational excellence and enhance workflows in a fast-paced environment through collab...
3 weeks ago
Associate Director, Regulatory Affairs - CMC
$169K - $212K *
Shape global regulatory CMC strategies for small molecule drug submissions. Lead cross-functional collaboration to ensure timely and compliant documentation for INDs, NDAs, and lifecycle management, w...
3 weeks ago
$100K - $130K *
Engineer quality solutions in the medical device sector. Oversee compliance, drive risk management, and enhance product quality. Collaborate with teams throughout product lifecycle ensuring adherence...
2 weeks ago
$75K - $95K *
Shape quality assurance processes to support new product development, ensuring compliance and mitigating risks through leadership and data analysis in a fast-paced, regulated environment...
2 weeks ago
Senior Specialist, Engineering
$117K - $184K *
Drive operational excellence in a new manufacturing facility, acting as a subject matter expert to support startup, commissioning, and ongoing operations while collaborating with cross-functional team...
2 weeks ago
Senior Managing Regulatory Scientist
$174K - $213K *
Champion regulatory excellence in food safety and nutrition, leveraging deep expertise to guide clients through complex compliance challenges and develop impactful strategies for product approvals and...
4 days ago
$88K - $110K *
Join a team that's dedicated to regulatory excellence in wellness and medical devices, ensuring compliance with global standards while providing support across product development and registration pro...
2 weeks ago
Principal Regulatory Affairs Specialist - Diabetes Care (on-site)
$100K - $200K *
Make your mark at the forefront of diabetes innovation, leading regulatory strategies for groundbreaking medical devices and ensuring compliance throughout product development, ultimately improving pa...
Reposted 2 weeks ago
Associate Director, Sterility Assurance
$142K - $256K *
Oversee and enhance sterility assurance by designing and implementing Contamination Control Strategies aligned with regulatory standards. Collaborate closely with cross-functional teams to drive conti...
Reposted 5 days ago
$160K - $185K *
Contribute to high-quality regulatory submissions for oncology products, collaborating cross-functionally to support timely and strategic regulatory operations. Thrive in a dynamic environment that va...
3 days ago
$145K - $165K *
Contribute to strategic regulatory submissions and enhance oncology product development. Collaborate with cross-functional teams to ensure compliance, manage timelines, and communicate effectively whi...
3 days ago
Senior Quality Assurance Specialist
$75K - $95K *
Develop quality assurance strategies to ensure compliance with cGMP standards, lead investigations, oversee quality systems, and promote continuous improvement to elevate product quality and operation...
Yesterday
Director, Regulatory Affairs (Hybrid)
$120K - $150K *
Pioneer regulatory excellence by leading global product registrations, ensuring compliance, and guiding teams through complex submissions in the medical device sector for enhanced patient outcomes...
5 days ago
Regulatory & Compliance Specialist
$90K - $95K *
Contribute to compliance excellence in IVD product development by ensuring all regulatory requirements are met. Work collaboratively with teams to uphold quality standards throughout the entire lifecy...
6 days ago
Sr Quality Engineer, Design Assurance
$81K - $112K *
Optimize product quality and compliance through management of design validation, risk analysis, and continuous improvement initiatives while collaborating across teams in medical device development pr...
4 weeks ago
Sr Quality Engineer, Design Assurance
$81K - $112K *
Empower product development by managing quality assurance efforts for new and existing designs, ensuring compliance and risk mitigation through collaboration across engineering, regulatory, and market...
4 weeks ago
Sr Quality Engineer, Design Assurance
$81K - $112K *
Champion the quality and compliance of innovative medical device products by leading design quality assurance efforts throughout the product lifecycle. Collaborate cross-functionally to ensure robust...
4 weeks ago
Sr Quality Engineer, Design Assurance
$81K - $112K *
Join a team that's committed to enhancing product quality through effective design assurance. Collaborate with cross-functional teams on new product development and risk management, ensuring complianc...
4 weeks ago
Sr Quality Engineer, Design Assurance
$81K - $112K *
Lead the charge in quality assurance and risk management for innovative medical devices. Collaborate with cross-functional teams across all development phases, ensuring compliance and excellence in pr...
4 weeks ago
Senior Manager, Regulatory Affairs - Lingo (on-site)
$130K - $261K *
Champion regulatory excellence by leading submission strategies and compliance initiatives. Drive a diverse team towards innovative healthcare solutions while ensuring adherence to global regulatory s...
3 weeks ago
Technical Oversight Specialist
$100K - $140K *
Champion quality and safety in building products evaluation by leading compliance assessments and mentoring junior engineers. Join us to drive innovation in construction standards and ensure client sa...
Reposted 6 days ago
Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
$190K - $300K *
Shape the future of cardiovascular development by leading global regulatory strategies. As a Senior Principal Scientist, you will drive approval processes for complex drug programs, serving as the str...
5 days ago
Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
$190K - $300K *
Optimize global regulatory strategies for drug programs in cardiovascular metabolic areas. Lead cross-functional teams to secure approvals and navigate regulatory challenges effectively while fosterin...
5 days ago
Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
$190K - $300K *
Champion global regulatory strategies for cardiovascular programs to achieve optimal labeling and expedite approvals. Leverage expertise in drug development while managing complex programs as a key re...
5 days ago
Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
$190K - $300K *
Redefine global regulatory strategy by leading complex cardiovascular programs, driving optimal results with minimal oversight while engaging with global regulatory agencies for timely approvals and c...
2 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.