Senior Associate, Regulatory Affairs

Corcept Therapeutics; Redwood City (CA); On-site; USD 126,000 - 177,000; Full time

Job summary

Corcept Therapeutics, headquartered in Redwood City, CA, seeks a Senior Associate, Regulatory Operations to support regulatory submissions and document management. The role reports to the Director of Regulatory Operations and collaborates with the Regulatory group, vendors, and cross-functional teams.

Candidates should have a BA/BS in a scientific discipline and at least 3 years of regulatory experience in pharma.

Qualifications

• BA/BS degree in a scientific discipline.
• 3+ years of relevant regulatory experience in the pharmaceutical industry.
• Experience with Veeva Vault systems is preferred.

Responsibilities

• Compile, format, and publish electronic regulatory submissions to health authorities.
• Maintain the Veeva Vault RIM system and ensure regulatory records are up to date.
• Support GxP change control processes in Veeva Vault.
• QC regulatory documents prior to submission to health authorities.
• Collaborate with external publishing vendors for e-submission files and receipts.
• Manage the tracker with weekly/monthly regulatory submissions and communicate with the Regulatory group.
• Maintain templates and style guides for regulatory submissions.
• Participate in development of Standard Operating Procedures (SOPs).
• Support Regulatory team members with filings and projects as needed.

Skills

Attention to detail

Excellent written and spoken English

Team player

Multitasking

Time management

Self-motivated

Education

BA/BS in a scientific discipline

Tools

Veeva Vault

Job description

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California.

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.

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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $125,600-$177,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

Please visit our website at: https://www.corcept.com/