"Regulatory Specialist C"

Job Description Summary

Regulatory Affairs as a field is concerned with ensuring that clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn), regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff assist in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Regulatory Affairs Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials.

Job Description

The Regulatory Affairs Specialist C will lead the coordination of unit research, including but not limited to Phase I-IV clinical trials. The Regulatory Affairs Specialist C will, independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees. Regulatory applications may include new study submissions, pre-IND/Pre-IDE submissions, annual reports, amendments, adverse events, and reportable events. They will independently prepare and process all required regulatory documentation for Sponsor Oversight and independent DSMB or Medical Director assessment, as well as organize and maintain all regulatory affairs documentation/Trial Master files (TMF) as required. The Regulatory Affairs Specialist C is expected to resolve regulatory and data queries as required, and lead the conduct of initiation, oversight, and close-out activities related to the conduct of the research by vendors. They will lead study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Specialist C is expected to lead the development of unit guidance/process documents, including work tools, and contribute to the development/maintenance of study-specific case report forms for FDA reporting, as well as provide direct regulatory/compliance guidance. The Regulatory Affairs Specialist C will serve as a mentor and/or trainer to more junior members of the regulatory research team/study team. Additional duties relevant to regulatory affairs as assigned.

The Regulatory Affairs Specialist C functions independently with minimal supervision on complex protocols that are Investigator Initiated. The Regulatory Affairs Specialist C authors and conducts regulatory assessments of core documents (protocols, Informed Consents, investigator brochure, etc), and is responsible for leading and drafting IND briefing books and Q-submissions, new IND/IDE applications, sponsor reports, and facilitates all communications with the reviewing entities (including FDA and other federal/state/local agencies, per application). The Regulatory Affairs Specialist C will be aware of intellectual property and assist in the management, per Penn COI Policy. They will also be aware of agreements with outside parties to ensure appropriate Sponsor Oversight. The Regulatory Affairs Specialist C, prepares submissions to the FDA in CTD or eCOPY format, conducts quality reviews of all regulatory documents for submission and any data reports, and advises on and ensures appropriate oversight of Sponsor vendors.

The Regulatory Affairs Specialist C reviews relevant safety information, obtains feedback from other appropriate parties, and identifies potential impacts to other protocols/staff. Additionally, the Regulatory Affairs Specialist C monitors regulatory news related to assigned activities, and translates into operational changes, as needed. The Regulatory Affairs Specialist C assists in creating new operating procedures and work instructions, supports orientation and training of new staff, provides regulatory training to others, and advises faculty on translation of research from bench to bedside. The Regulatory Affairs Specialist C helps create new tools (I.e., procedures, work instructions, templates). This individual communicates independently at all levels and ensures audit/inspection readiness of assigned projects. The Regulatory Affairs Specialist C would review complex exemption requests (protocols that may include products other than drugs/devices).

Job Responsibilities

• Regulatory Affairs Specialist C will lead the coordination of unit research, including but not limited to Phase I-IV clinical trials... [detailed as above]
• The Regulatory Affairs Specialist C functions independently with minimal supervision on complex protocols... [detailed]
• The Regulatory Affairs Specialist C reviews relevant safety information... [detailed]
• The Regulatory Affairs Specialist C will serve as a mentor and/or trainer to more junior members...

Qualifications

Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required. Associated research credentialing (ACRP, RAC, CCRP, CIP, etc.) preferred.

The successful candidate must have effective problem solving and critical thinking abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; thorough and demonstrated knowledge FDA and ICH. Prior education or experience with IND/IDE/Expanded Access Applications, drug development process, medical writing, and clinical trial operations required. Knowledge of appropriate submission mechanisms to different FDA centers (paper, email, NextGen Portal, Electronic Submission Gateway (ESG)) required; knowledge of at least one electronic submission pathway strongly preferred.

The successful candidate must be self-driven with heightened attention to detail. Candidates must desire to work in a fast-paced environment with competing priorities. Candidates should welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth. Candidates should desire to mentor/foster the growth of peers and have experience training peers in a research setting. Candidates must have a high level of general computing ability.

Intermediate/expert level of function in all of the Microsoft Office applications, as well as, applications for team interconnectivity such as Slack, Microsoft Teams, Zoom, WebEx, etc. Knowledge and/or experience publishing and working with web-based e-regulatory document management systems such as Veeva Systems products, etc. is a plus.

Working Conditions

Hybrid Eligible - This position is eligible for a hybrid work schedule... largely remote.

Targeted Pay Range

$77,920 - $85,907 Annual

Job Location

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

To apply, visit this link