Regulatory Affairs Specialist
455 Mission Bay Blvd. (South) San Francisco, CA 94158
Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients.
- Under the direction of AD Regulatory Operations, assists in gathering and assembling information necessary for submissions in accordance with regulations and relevant guidelines.
- Maintains regulatory submissions and correspondence archives for Company sponsored projects, and all company related sections for partner sponsored projects.
- Provides general administrative support to Regulatory Operations staff including formatting and processing submissions documents, assembling and preparing briefing books for FDA submissions.
- Follows general instructions to complete projects. Organizes workday to complete mid-term assignments.
- Must be able to demonstrate excellent organizational, planning and follow-up skills.
- Excellent word processing, and graphic documentation skills are required.
- Must be able to demonstrate a good attention to details and be goal-oriented, and quality conscientious.
- Strong computer skills in Word, Excel and Adobe Acrobat Pro, with a working knowledge of electronic publishing/file management systems are an asset.
- Strong oral and written communication skills are required.
- Must be able to adapt to changing priorities and manage multiple tasks.
- A minimum of a Bachelor’s degree in a scientific discipline is preferred.
- Equivalent experience may be accepted.
- A minimum of 2 years related industry experience is required.
- A minimum of 2 years hands-on Regulatory Affairs experience preferred.