Regulatory Affairs Specialist

Lurie Children's Hospital•Chicago, IL

14d

About The Position

Under the direction of Director, Regulatory and Quality Assurance within the Office of Research Integrity & Compliance this position serves as an essential resource within the Medical Center, providing technical expertise and regulatory guidance for the research community with a focus on the development of pre-market regulatory submissions for drugs, biologics and devices, ensuring compliance with the Food and Drug Administration (FDA), Institutional Review Board (IRB), and Institutional Biosafety (IBC), as applicable. The Regulatory Affairs Specialist will collaboratively liaise with several groups to facilitate regulatory and operational compliance, including the Office of Clinical and Community Trials (OCCT), principal investigators (PIs), research fellows and regulatory coordinators.

Requirements

Bachelor’s degree in a related field required.
A minimum of 5 years substantive experience in research or a regulated field with at least two years of experience in regulatory affairs, clinical research, or a related area within the pharmaceutical, biotech, or medical device industries.
Familiarity with FDA submission processes and understanding of related regulatory requirements associated with the development, evaluation and approval process of regulated products.
Strong organizational, analytical, and project management skills, with an emphasis on detail, accuracy and customer service.
Ability to apply sound judgment and take initiative, engage relevant stakeholders as well as identify and resolve quality issues.
Excellent communication skills for interacting with regulatory agencies and cross-functional teams.
Ability to effectively communicate with all levels of the organization, including good presentation and training skills.
Excellent customer service, project management, and process improvement skills.
Ability to take initiative, prioritize tasks to meet deadlines, produce results and cope with the inherent pressures.
Ability to perform multiple tasks with a high level of accuracy and attention to detail.
Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical record (EPIC).

Nice To Haves

Master’s or PhD degree in Biology, Chemistry or Life Sciences or equivalent (e.g. MD or PharmD) degree preferred.
Industry experience preferred.
Certification or eligibility to sit for Certification Exam in relevant area (i.e., Certified IRB Professional (PRIM&R), Certified Clinical Research Professional (SOCRA), Certified Clinical Research Coordinator or Associate (ACRP), Society for Quality Assurance and the American Society for Quality, etc.).

Responsibilities

Maintain comprehensive knowledge of regulatory standards and guidelines governing the development of drug, biologic and device products.
Stay informed on emerging trends, regulations, and technologies related to regulated products to identify opportunities for process improvements and streamline regulatory processes.
Reviews, evaluates, and advises on submissions in coordination with PIs/research teams to ensure compliance with regulatory standards for initial investigational new drug/device applications, expanded access protocols, protocol submission, and various maintenance applications including amendments, annual reports and safety reports.
Collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included. Complex projects may include considerations for commercialization, manufacturing, and/or pre-clinical animal studies.
Participate in Regulatory Agency meetings in a regulatory support function.
Perform duties involved in the organization, documentation and compilation of regulatory documents.
Support study teams on communications with Regulatory Agencies to facilitate submissions, resolve inquiries, and address any issues that may arise.
Provide regulatory advice to Manne Research Institute sponsor-investigators and their research teams by explaining and interpreting regulations and encouraging adherence to Regulatory Agency guidance.
Work to identify potential problems and/or inconsistencies and make corrections as appropriate.
Encourage best practices among all Lurie Children’s Hospital investigators.
Serve as a Regulatory Agency contact for Lurie Children’s Hospital investigators and help resolve issues in a timely manner.
Develop and maintain regulatory trackers and databases to monitor submission timelines, track regulatory changes, and communicate updates to relevant stakeholders.
Support the IRB and Quality Assurance team by reviewing or auditing regulated research studies, with a focus on Investigator-Initiated research, and evaluating them for regulatory issues.
Identify training opportunities related to investigator-initiated research study submissions.
Disseminate information to research community through initiatives in education, training and operations in coordination with the Office of Research Development (ORD).
Assist with new and ongoing research projects related to regulatory issues, with the objective to publish the research findings.
Other duties as assigned.

Benefits

Medical, dental and vision insurance
Employer paid group term life and disability
Employer contribution toward Health Savings Account
Flexible Spending Accounts
Paid Time Off (PTO), Paid Holidays and Paid Parental Leave
403(b) with a 5% employer match
Various voluntary benefits: Supplemental Life, AD&D and Disability Critical Illness, Accident and Hospital Indemnity coverage
Tuition assistance
Student loan servicing and support
Adoption benefits
Backup Childcare and Eldercare
Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members
Discount on services at Lurie Children’s facilities
Discount purchasing program