Corcepttherapeutics
Senior Associate, Regulatory Affairs
Redwood City, California, United States. Posted a month ago
The role
The Senior Associate, Regulatory Operations will support various regulatory activities. This person will work with the Regulatory group, other departments, and vendors to manage regulatory requirements and submissions.
What you will do
- Compile, format, and publish electronic regulatory submissions to health authorities
- Support Regulatory Operations members with maintaining the Veeva Vault RIM system and ensuring all regulatory records are up to date
- Support GxP change control processes in Veeva Vault
- Support the QC of regulatory documents prior to submission to health authorities
- Collaborate with external publishing vendors for e-submission files and submission receipts
- Manage the tracker with all weekly/monthly regulatory submissions and communicate information with the Regulatory group
- Maintain templates and style guides for regulatory submissions
- Participate in the development of Standard Operating Procedures (SOPs)
- Support Regulatory team members with regulatory filings and projects, as needed
Required qualifications
- 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 have
- Experience with Veeva Vault systems
- Experience with electronic submissions to the EU health authority
- BA/BS degree in a scientific discipline
- 3+ years of relevant regulatory experience in the pharmaceutical industry
Before you apply
- Applicants must be currently authorized to work in the United States on a full-time basis
About the company
Corcept is headquartered in Redwood City, California. The company is focused on the science of cortisol and has a commercial portfolio including treatments for hypercortisolism and oncology.