Regulatory Affairs Manager
7 days ago
Corcept Therapeutics is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the company's regulatory interface with domestic and international health authorities.
Key Responsibilities- Manage the development and deployment of the regulatory program to ensure aggressive product approval
- Manage and generate regulatory submission documents for new products or changes to existing health authorities' filings
- Determine governmental regulations affecting company processes and assure the processes are complete and accurate to ensure company compliance
- Partner with various teams throughout the organization on projects
- Work with the clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations
- 5+ years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries
- Strong analytical and problem-solving skills
- Strong written and verbal communication skills, including the ability to interact effectively and to influence
- Strong attention to detail
- Customer-focused and adaptable, with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations
- Bachelor's or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline
Corcept Therapeutics offers a competitive salary and benefits package, including a comprehensive health insurance plan, 401(k) matching, and paid time off.
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International Regulatory Affairs Manager
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Redwood City, California, United States Pulmonx Corporation Full timeManager, Regulatory Affairs, InternationalPulmonx is a leading entity in the field of Interventional Pulmonology, specializing in innovative tools and therapies for Obstructive Lung Disease. Our commitment to excellence is exemplified by our flagship product, the Zephyr Valve, which has been recognized for its groundbreaking technology in the realm of...
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International Regulatory Affairs Manager
1 month ago
Redwood City, California, United States Pulmonx Corporation Full timeManager, Regulatory Affairs, InternationalPulmonx is a leading innovator in the field of Interventional Pulmonology, specializing in advanced tools and therapies for Obstructive Lung Disease. The company is recognized for its groundbreaking Zephyr Valve, which received breakthrough designation from the FDA due to its significant clinical advantages in lung...
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International Regulatory Affairs Manager
1 month ago
Redwood City, California, United States Pulmonx Corporation Full timeManager, Regulatory Affairs, InternationalPulmonx is a recognized leader in the field of Interventional Pulmonology, specializing in innovative tools and therapies for obstructive lung diseases. Our flagship product, the Zephyr Valve, has received significant accolades, including breakthrough designation from the FDA due to its unique approach to lung volume...
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International Regulatory Affairs Manager
1 month ago
Redwood City, California, United States Pulmonx Corporation Full timeManager, Regulatory Affairs, InternationalPulmonx is a recognized leader in the field of Interventional Pulmonology, specializing in innovative planning tools and treatments for obstructive lung diseases. With operations in multiple global locations, Pulmonx is renowned for its Zephyr Valve, a device that received breakthrough designation from the FDA in...
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International Regulatory Affairs Manager
1 month ago
Redwood City, California, United States Pulmonx Corporation Full timeManager, Regulatory Affairs, InternationalPulmonx is a leading entity in the field of Interventional Pulmonology, specializing in innovative solutions and therapies for Obstructive Lung Disease. The company is recognized for its development of the Zephyr Valve, a device that has achieved breakthrough status and received FDA approval due to its significant...
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International Regulatory Affairs Manager
1 month ago
Redwood City, California, United States Pulmonx Corporation Full timeManager, Regulatory Affairs, InternationalPulmonx is a leading organization in the field of Interventional Pulmonology, offering innovative solutions and therapies for Obstructive Lung Disease. The company is recognized for its development of the Zephyr Valve, a groundbreaking device that received breakthrough designation from the FDA in June 2018, as it...
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Regulatory Affairs Director
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Regulatory Affairs Director
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