Manager, Regulatory Operations
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ:FPRX) discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime's comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company's R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.
We are looking for a talented Regulatory Operations Manager who will lead functional activities related to regulatory operations/submissions. This position manages a direct report and reports to Vice President, Regulatory Affairs.
- Provide oversight on all regulatory operations and submissions
- Prepare, compile, scan, render, QC and publish documents of new and existing regulatory applications, including initial applications (INDs), amendments, variations and other submissions in the eCTD format for submission to US and international agencies in compliance with FDA, ICH, and other health authority regulations and guidance, and internal style guide.
- Manage and maintain regulatory systems and tools, such as EDMS, RIMs, shared drives, etc
- Design and provide formal internal training on templates and other submission-related documentation and systems
- Provide input on or write processes and SOPs in relation to regulatory operations or multifunctional procedures for submissions
- Provide publishing guidance and input and timing on project submission team timelines
- Perform complex compilation and publishing activities of new and existing regulatory applications
- Manage vendors and contracts
- Coach and mentor associates, provide work oversight, prioritize work and manage timelines
- Other projects as needed
- B.A./B.S. degree in life sciences or technical writing
- 5+ years of direct regulatory experience in biotechnology environment
- Prior managerial experience is desirable
- Working knowledge of FDA regulations and ICH guidances
- Excellent written and interpersonal communication skills
- Ability to lead and work with others in a positive and collaborative manner
- Proficient experience with electronic submissions and eCTD structure with submission publishing software
- Experience with electronic data management systems (EDMS) and regulatory documentation archival required
- Proficient experience with submission publishing software and tools e.g. OmniFile, Insight Publisher, ISI toolbox, etc
- Expert use of MS Office
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.