Senior Associate, Regulatory Affairs
Corcept Therapeutics
Summary
The Senior Associate, Regulatory Operations will report to the Director of Regulatory Operations and will support various regulatory activities. The Senior Associate will work with members of the Regulatory group, other departments, and vendors to manage regulatory requirements and submissions.
Job description
Responsibilities
- Compile, format, and publish electronic regulatory submissions to health authorities
- Supporting Regulatory Operations members with maintaining the Veeva Vault RIM system and ensuring that all regulatory records are up to date
- Supporting GxP change control processes in Veeva Vault
- Supporting the QC of regulatory documents prior to submission to health authorities
- Collaborate with external publishing vendors for e-submission files and submission receipts
- Managing the tracker with all weekly/monthly regulatory submissions and communicating information with the Regulatory group
- Maintaining templates and style guides for regulatory submissions
- Participating in the development of Standard Operating Procedures (SOPs)
- Supporting Regulatory team members with regulatory filings and projects, as needed
Preferred Skills, Qualifications and Technical Proficiencies
- Experience with Veeva Vault systems is preferred
- Experience with electronic submissions to the EU health authority is a plus
- Detail oriented with excellent oral and written communication skills
- Strong team player, self-motivated and able to function independently as well as part of a team
- Able to work on multiple projects concurrently and adapt to a continuously changing environment
- Proficient in organization, prioritization, and time management
- Experience with Microsoft Word, PowerPoint and Excel
Preferred Education and Experience
- BA/BS degree in a scientific discipline
- 3+ years of relevant regulatory experience in the pharmaceutical industry
Requirements
- BA/BS degree in a scientific discipline
- 3+ years of relevant regulatory experience in the pharmaceutical industry
- Experience with Veeva Vault systems is preferred
- Experience with electronic submissions to the EU health authority is a plus
- Detail oriented with excellent oral and written communication skills
- Strong team player, self-motivated and able to function independently as well as part of a team
- Able to work on multiple projects concurrently and adapt to a continuously changing environment
- Proficient in organization, prioritization, and time management
- Experience with Microsoft Word, PowerPoint and Excel
Company overview
Corcept Therapeutics Inc. is a commercial-stage pharmaceutical company founded in 1998 and headquartered in Redwood City, California. The company specializes in the discovery, development, and commercialization of medications that treat severe metabolic, oncologic, and neuropsychiatric disorders by modulating the effects of the hormone cortisol. Corcept's primary focus is on addressing the adverse effects of excess cortisol, which can lead to life-threatening conditions including Cushing's syndrome, various cancers, diabetes, and neurological disorders. The company's flagship product is Korlym (mifepristone), the first FDA-approved oral therapy for treating hyperglycemia in adult patients with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance. With approximately 500 employees, Corcept has developed a large portfolio of proprietary compounds that selectively modulate cortisol effects without compromising progesterone function. The company maintains extensive intellectual property covering its selective cortisol modulators and continues to advance clinical trials for potential treatments of hypercortisolism, advanced ovarian cancer, prostate cancer, ALS, and MASH.