Regulatory Affairs Specialist
Regulatory Affairs | San Francisco, Ca | Full Time
The Parker Institute for Cancer Immunotherapy (PICI) is radically changing the way cancer research is done. Founded in 2016 through a $250 million gift from Silicon Valley entrepreneur and philanthropist Sean Parker, the San Francisco-based nonprofit is an unprecedented collaboration between the country’s leading immunotherapy researchers and cancer centers, including Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center. The institute also supports top researchers at other institutions, including City of Hope, Dana-Farber Cancer Institute, Fred Hutchinson Cancer Research Center, Icahn School of Medicine at Mount Sinai, Institute for Systems Biology and Washington University School of Medicine in St. Louis.
By forging alliances with academic, industry and nonprofit partners, PICI makes big bets on bold research to fulfill its mission: to accelerate the development of breakthrough immune therapies to turn all cancers into curable diseases.
Help us create a world that doesn’t fear cancer. Join us. www.parkerici.org
Overview of the Role
The Regulatory Affairs Specialist will work in the Regulatory Affairs (RA) department to coordinate, compile and submit regulatory submissions to FDA in support of PICI clinical development projects. The successful candidate ensures attention to detail and high-quality packages preparing regulatory submissions in line with ICH requirements, regional requirements and scientific and company policies and procedures. S/he participates in cutting edge novel immunotherapy combination treatments for cancer with a wide range of investigational agents from small molecules, biologics, cell and gene therapy and maintains knowledge of regulatory guidelines and policies.
Reporting Structure and Team
The Regulatory Affairs Specialist reports to the Vice President, Translational Medicine and Regulatory Affairs and is a key member of the Regulatory Affairs team.
NOTE: This role will be required to be onsite full time in our San Francisco office post COVID.
FLSA Status: Exempt
Essential Job Functions
Prepares and maintains regulatory submissions for immunotherapy programs in oncology interacting with multiple divisions at the FDA.
Coordinates, compiles and submits regulatory submissions, including IND annual reports, quarterly safety reporting, maintains of clinicaltrials.gov and other customary required submissions.
- Represents RA on cross-functional project teams. Guide teams with input from senior RA professionals to provide content for FDA routine submissions, participates in reviews as needed.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the RA, Quality Assurance and project teams.
- Performs document filing and retrieval functions as directed, or in conjunction with PICI SOPs.
- Seeks assistance from appropriate internal and external resources.
- Communicates with and maintain productive, constructive relationships with project team and external partners.
- Support RA department and Institute initiatives as identified by management and in support of Quality Management Systems (QMS), and other compliance requirements.
- Complies with regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Must be familiar with US regulatory requirements for IND and early phase clinical studies.
Knowledge, Skills, and Experience
- Bachelor’s Degree in science preferred.
- Minimum of 1-2 years’ regulatory experience in early phase clinical development with some experience in oncology strongly desired.
- Experience with biologics, gene therapy, cell therapy or other complex biologics desired.
- Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, clinical affairs, operations, or related area.
- Experience with word processing and spreadsheet software packages is required.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate and collaborate with a technical team
- Multitasks, prioritizes and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail