Senior Associate, Regulatory Affairs

Corcept Therapeutics•Redwood City, CA

6d•Onsite

About The Position

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.

Requirements

BA/BS degree in a scientific discipline
3+ years of relevant regulatory experience in the pharmaceutical industry
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

Nice To Haves

Experience with Veeva Vault systems is preferred
Experience with electronic submissions to the EU health authority is a plus

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