Regulatory Affairs Specialist

Ann & Robert H. Lurie Childrens Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence kids and their families are at the center of all we do. Ann & Robert H. Lurie Childrens Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.

General Summary:

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.

Essential Job Functions:

• 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 Childrens Hospital investigators. Serve as a Regulatory Agency contact for Lurie Childrens 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.

Knowledge Skills and Abilities:

• Bachelors degree in a related field required. Masters or PhD degree in Biology Chemistry or Life Sciences or equivalent (e.g. MD or PharmD) degree preferred.
• 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. Industry experience preferred.
• 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.
• 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.).
• 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).

Education

Pay Range

At Lurie Childrens we are committed to competitive and fair compensation aligned with market rates and internal equity reflecting individual contributions experience and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions.In addition to base salary Lurie Childrens offer a comprehensive rewards package that may include differentials for some hourly employees leadership incentivesfor select roles health and retirement benefits and wellbeing programs. For more details on other compensation consult your recruiter or click the followinglink to learn more about our benefits.

Benefit Statement

For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes:

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 Childrens facilities

• Discount purchasing program

Theres a Place for You with Us

At Lurie Childrens we embrace and celebrate building a team with a variety of backgrounds skills and viewpoints recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly appreciate differences and make meaningful connections that foster belonging. This is a place where you can be your best so we can give our best to the patients and families who trust us with their care.

Lurie Childrens and its affiliatesare equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race color sex sexual orientation gender identity or expression religion national origin ancestry age disability marital status pregnancy protected veteran status order of protection status protected genetic information or any other characteristic protected by law.

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