Senior Manager, Regulatory Affairs Operations
San Francisco, California
A biopharmaceutical firm, dedicated to developing innovative ways to treat and ultimately defeat fibrosis and Oncology, is searching for a new created role for a Sr. Manager, Regulatory Affairs. This billion-dollar public organization, which specializes in the clinical stages, currently has two treatments in Phase II of development, one in phase I, and a strong preclinical pipeline to back it up. You will play a key role on the company's regulatory affairs team as you will be responsible for ensuring regulatory systems and executing all global regulatory submissions.
The Senior Manager of Regulatory Affairs Operations will be responsible for:
- Supervise regulatory submissions (Safety Reports, INDs, etc.)
- Development of Veeva RIM
- Implement current and future guidelines from health agencies
- Advance the development of process documentation
An ideal candidate for this role will have:
- Strong understanding of the eCTD system
- Lifecycle management for MAAs, CTAs, INDs, NDAs
- Veeva Vault RIM experience
This firm values its employees as change makers and offers competitive compensation packages.
- Health insurance
- 401(k) plan with match
- Annual bonus
If you're interested in this position, email firstname.lastname@example.org to apply now!