Regulatory Affairs Specialist II
Job Title: Regulatory Affairs Specialist II
Position Summary and Key Responsibilities
The Regulatory Affairs Specialist II is responsible for coordinating and supporting regulatory affairs activities relating to all City of Hope sponsored INDs, investigator-initiated INDs, and Drug Master Files (DMF). This includes assistance with preparation of initial Phase I/II clinical trial IND filings and maintenance of the IND in the setting of an academic research organization. The position will assist in the development and implementation of regulatory strategies for interacting with regulatory agencies and will act as a liaison with the FDA, NIH-OBA, and institutional regulatory committees. This position will provide staff expertise and preparatory assistance to Regulatory Affairs management in preparation of documents for regulatory submissions to applicable regulatory agency(ies). He/she will ensure regulatory affairs compliance of clinical trials under a COH-sponsored IND.
- Normally receives no instructions on routine work, and general instructions on new assignments. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Under direction of the Director of OIDRA or designee, establishes and implements standards, approaches, methods, and procedures for the various regulatory affairs activities relating to the development and implementation of novel therapeutics.
- Serves as a project lead for portions or all sections of an IND filing, NIH OSP filing, international filing, or DMF filling, as applicable.
- Reviews technical data and reports to ensure consistency of data provided in the IND and other regulatory submissions.
- Prepares for and serves as the regulatory affairs liaison in Trial Initiation Meetings and project meetings for COH-sponsored INDs, as required.
- Oversees and organizes documentation of user instructions and prepare standard operating procedures (SOPs) for clinical trials conducted under a COH-sponsored IND.
- Provides assistance and support to Principal Investigators, for timely and accurate submissions of annual reports or other regulatory documents required by the FDA. Prepares and files annual reports and other regulatory documents to internal and external regulatory committees as needed.
- Ensures compliance to institutional and federal applicable regulatory and quality policies and FDA guidance rulings, as well as ensuring compliance with Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) guidelines for all research programs.
- Assist with preparing, filing and maintaining regulatory documents to COH oversight committees such as OSBC, radiation safety, IBC, CPRMC, IRB, IACUC, and SCRO as needed. Follows HIPAA guidelines.
- Maintains electronic databases of files related to compliance of institutional and federal guidelines and maintain current knowledge of regulations and guidances.
- Under direction of the Director or designee, reports all Serious Adverse Events (SAEs) to applicable regulatory agency (ies).
- Assists with preparation of grants and papers with respect to their interaction with regulatory agencies.
- Provides guidance to physicians, CPRMC, PRMC, DSMC and IRB in the interpretation of GCP, IRB, and FDA regulations and guidelines.
- Participate in clinical trials adherence evaluations and compliance audits.
- Participates in the training of staff, as needed.
- Facilitates internal and external regulatory agency inspections.
- Is responsible for continued development and maintenance of quality assurance programs.
- Maintains professional growth and development through seminars, workshops, and professional affiliations to maintain certification/licensure and/or keep abreast of latest trends in the field of expertise.
- Is self-motivated in organizing and following through on assigned projects.
- Ensures work environment is organized and functions efficiently.
- Attends and participates in meetings as required.
- Tolerates flexible work hours to achieve critical deadlines.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code 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:
- Requires a Bachelor's degree in a scientific discipline or equivalent. Experience may substitute for minimum education requirements.
- A minimum of 5 to 7 years related experience with a Bachelors or 3 to 6 years with a Masters, or 2 to 5 years with a PhD, and demonstrated working knowledge of scientific principles.
- Must possess excellent written/editorial, interpersonal, verbal communications and computer literacy skills.
- Certification in Regulatory Affairs, preferred.
- Prior eCTD publishing experience, highly desirable.
- Cellular and gene therapy experience preferred.
- Pre-clinical experience, preferred.
- Up to date familiarity with regulations pertaining to INDs involving CDER, CBER and NIH-OBA activities, including experience as an auditor, quality control coordinator, or compliance officer.
- Computer skills including Microsoft Windows, Word and Excel, Adobe Acrobat.
- Must communicate technical information in a clear, concise manner.
- Ability to monitor and train other employees.
- Ability to master content across all clinical research areas.
- Previous supervisory experience, preferred.
- Foster and promote a positive image.
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 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.
City of Hope is 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.