Regulatory Affairs Specialist III | CAR T
City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
Job Title: Regulatory Affairs Specialist III| CAR T
Position Summary and Key Responsibilities:
The Regulatory Specialist III is responsible for supporting the regulatory affairs activity in all activities relating to all City of Hope INDs/IDEs and COH sponsored INDs/IDEs for Phase I/II clinical trials in the setting of an academic research organization. The position will serve as the regulatory project lead in regulatory submissions, to include Pre- and Initial IND Filings and any corresponding Amendments.
- Under the direction of the Director of OIDRA, the Regulatory Specialist III will hold responsibility for the compilation, review and subsequent preparation of Pre and Initial IND filings, to include corresponding amendments to same. In this capacity, the Specialist III will direct and review the work of regulatory team members assigned to a given project. The Specialist III will consult with his/her Director, as needed, to resolve outstanding issues and to ensure timely and compliant regulatory filings.
- The following are essential job accountabilities:
- Under supervision of Director, OIDRA, will hold responsibility for Pre-IND and Initial IND/IDE filings. Responsibility will encompass compilation of data, authoring of sections (as required), and accuracy/completeness of filing.
- Will supervise assigned staff in completion of regulatory filings, ensuring that workload assigned is being completed in a timely manner.
- Will advise assigned staff on issues pertaining to regulatory compliance, from the perspective of the FDA and any applicable external agency (e.g. NIH).
- Will work on an ongoing basis with other team members to ensure timely completion of other IND/IDE filings, as required, to include IND/Drug Master File Annual Reports, Protocol Amendments, Information Amendments and Safety Amendments. May be requested by Director to oversee certain types of filings, e.g. Safety Reporting, when the volume necessitates a single point of contact.
- Attend departmental meetings, advising team of status of projects assigned. When applicable, will request additional assistance to ensure timely completion of submissions.
- In conjunction with Director, will work to develop Standard Operating Procedures that are compliant with applicable regulatory requirements and COH guidelines.
- Provide assistance and support to Principal Investigators and other applicable parties, e.g. Pharmacy, Pharm/Tox, to ensure timely and accurate submissions of regulatory filings.
- Able to perform multi-tasks to ensure timely completion of filings.
- Must possess good communication skills; able to relate findings in a manner that is clear and concise (both written and verbal).
- May assist with preparation of grants and papers with respect to their interaction with regulatory agencies.
- Provides guidance to physicians, CPRMC, PRC and IRB in the interpretation of GCP, IRB, OBA/RAC and FDA guidelines.
- In conjunction with Director, will assist with internal and external regulatory inspections. In the absence of the Director, will assume lead position if requested by Sr. Vice President of CATD.
- Is self-motivated in organizing and following through on assigned projects.
- Ensure work environment is organized and functions efficiently.
- Attend and participates in meetings as required. When applicable, will lead meetings pertaining to assigned filings.
- Internal Contacts: Will interface within other departments of Center for Biomedicine and Genetics to include Quality Assurance and Quality Control. In addition, will interface with Principal Investigators and/or their staff, as required.
- External Contacts: Will interface with outside vendors to include NGVL, NIH/OBA or outside contracted parties involved in the conduct of a study. In addition, will interface with the FDA on major submission filings.
- Budget/Financial Administration: Not applicable.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
Minimum Education and Skills Required for Consideration:
- Bachelor's degree (degree in science preferred)
- Minimum Experience:A minimum of 8 plus years with a Bachelors, or 7 plus years with a Masters, or 6 plus years with a PhD.
- Computer skills including Microsoft Word and Excel. Experience in Adobe Acrobat a plus.
- Required Courses/Training:Science courses, preferred.
- Required Certification/Licensure:Regulatory Affairs Certification required either via a university program or through Regulatory Affairs Professional Society (RAPS).
- Preferred Education:Masters with 7 plus years related experience or Ph.D. with 6 plus years related experience (science discipline, preferred).
- Preferred Courses/Training:Regulatory Affairs coursework.
- Preferred Certification/Licensure:Certification in Regulatory Affairs required.
- Preferred Field of Expertise:Regulatory Affairs.
- Aptitude: Req./Pref.Supervisory skills
- Compose letters/memorandums
- Proofread documents
- Research information
- Prepare reports
- Manage projects
- Software:Microsoft Word, Microsoft Excel, Adobe Acrobat, a plus.
- Working / Environmental Conditions: Exposed to material of a confidential nature on a regular basis.
- Occasional pressure due to deadline requirements.
- Subject to interruptions.
- Subject to regularly changing priorities and work assignments.
- Tobacco free Campus.
- Physical Demands Light physical effort (lift/carry to 15 lbs).
- Occasionally lifts supplies and equipment.
- Occasional reaching, stooping, bending, kneeling.
- Some standing/walking.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.