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Sr Manager – Regulatory Affairs
| Company | Corcept Therapeutics |
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| Location | San Carlos, CA, USA |
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| Salary | $175000 – $215000 |
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| Type | Full-Time |
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| Degrees | |
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| Experience Level | Senior |
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Requirements
- 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
- High functioning as both a team player and individual contributor
Responsibilities
- Manages most aspects of company regulatory interface with domestic and international health authorities
- Manages the development and deployment of the regulatory program that ensures aggressive product approval
- Manages and may generate regulatory submission documents for new products or changes to existing health authorities’ filings, including domestic and international submissions and registration
- Manages the submissions of clinical study submissions
- Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure company compliance
- Partners with various teams throughout organization (Clinical Operations, R&D, Quality, etc.) on projects
- Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations
- Provides guidance with localization and labeling requirements
- Manages regulatory reporting
Preferred Qualifications
- Bachelor’s or advanced degree (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline
