Regulatory Affairs Associate II
San Rafael, California | Contract
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- Assemble FDA and ex-US regulatory filings and briefing books, leveraging subject matter experts.
- Work with supervisors and vendors to plan filing schedules.
- Work with publishing group to plan and finalize submissions.
- Research regulatory requirements.
- Minimum of 2 years experience in Regulatory Affairs in the biotechnology industry Prior experience managing ex-US regulatory filings and associated vendors/CROs is required.
- Prior experience reviewing Informed Consent Forms, Reviewing drug shipment packages, and eTMF filing highly desireable.
- Prior experience compiling filings for FDA submissions is highly desireable.
- Proficient with computer and standard software programs.
- Strong interpersonal and communication (written and verbal) skills.
- Effective task planning and coordination abilities.
- Capable of working with an interdisciplinary team.
- B.S. in life sciences or equivalent.