Regulatory Specialist - Regulatory Affairs Administration

Overview

Regulatory Specialist - Regulatory Affairs Administration

The Office of Research Regulatory Affairs (ORRA) Regulatory Specialist will be responsible for supporting a portfolio of drug and devices being developed and/or studied in clinical trials at Nationwide Children's Hospital and the Ohio State University. The Regulatory Specialist works with the ORRA to create and support regulatory filings to federal oversight agencies for investigator-initiated therapeutic and diagnostic products throughout the development lifecycle, from concept through product obsolescence. Provides support and guidance to investigators developing or repurposing a drug or device for human use. Provide support and guidance to the investigators and hospital administration for working within regulations to expedite the development, approval, and delivery of a safe and effective product to patients and research participants. Responsibilities include support in preclinical development through application for human clinical use.

Why Nationwide Children's Hospital?

The moment you walk through our doors, you can feel it. When you meet one of our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it, too. Welcome to Nationwide Children's Hospital, where Passion Meets Purpose.

Here, Everyone Matters. We're 14,000 strong. And it takes every single one of us to improve the lives of the kids we care for, and the kids from around the world we'll never even meet. Kids who are living healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.

Ask anyone with a Nationwide Children's badge what they do for a living. They'll tell you it's More Than a Job. It's a calling. It's a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.

Nationwide Children's Hospital. A Place to Be Proud

Responsibilities

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Writes, edits, reviews, and proofs regulatory documents (clinical protocols, manufacturing sections, informed consent documents, etc.) for submission to regulatory agencies (FDA, EU, PMDA).
• Reviews, compiles, and organizes material in preparation of submission packages (IND, IDE, etc.) for regulatory agencies.
• Provides quality control to regulatory documents, both internally created and externally received.
• Remains abreast of regulatory procedures and changes in regulatory climate, maintain records on legislation, regulations, and guidelines.
• Acts as a subject expert towards regulatory affairs intricacies in drug development subspecialties.
• Reviews and analyzes scientific and medical documentation, research and locate information on regulatory requirements of similar products.
• Provides guidance to investigators and leadership on regulatory issues.
• Applies regulatory affairs and ethical standards to all points of business.
• Assists in SOP development and review.
• Monitors and utilizes tracking and control systems of all regulatory submissions. Closely monitor submissions under review.
• Assists with QA documentation; data entry; and maintenance of regulatory documents. Maintain compliant regulatory files.
• Assists with organizing meetings with regulatory agency staff.
• Plans and supervises preparation of site visits by research sponsors and regulatory agencies.
• Assists with dissemination of data; coordination of visits with appropriate sites/labs.
• Plan, coordinate, and prepare for external quality assurance and control reviews.
• Actively participate in internal and external audits.
• Attends regulatory meetings. Submits minutes of complex committee meetings and composes large volume of in-depth critical correspondence based on committee deliberations. Issues approval notices based on conditions imposed by the committee.
• Attends regulatory professional meetings and surveys published literature for new or modified regulations that impact research on human or animal subjects.
• Provides administrative support for all aspects of ORRA.

Qualifications

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

Education:

• Bachelor's degree or an equivalent combination of education or experience.
• Minimum of 2 years' experience in pharmaceutical or medical device industry or a Master's degree.

Skills and Experience:

• Strong, proven writing experience in medical or scientific areas (samples will be requested).
• Strong skills in communication and collaboration internally and externally; working with investigators, clinicians, vendors, and subcontractors;
• Advanced written communication skills with high usage of word processing, spreadsheet and database software.
• Significant experience in drug or device regulations with knowledge and skills in regulatory pathways, preferably investigator-initiated submissions (IND, IDE).
• Demonstrate knowledge of regulations governing drug and device development by regulatory agencies (e.g., FDA, International Conference on Harmonization).
• Demonstrates ability to analyze and apply Federal, industry regulatory agencies and Hospital policies regarding human subject protection policies and procedures.
• Ability to exercise sound judgment and initiative in collecting technical information from a wide variety of sources.
• Ability to deal with large numbers of variables and determine specific course of action.
• Manage multiple projects and concurrent deadlines.
• Ability to initiate and compose correspondence to investigators and to produce accurate committee meeting minutes.
• Demonstrates working knowledge of research terminology.
• Demonstrates ability to work both independently and in a team-oriented environment, to follow through on assignments with minimal directions, and to independently prioritize work.
• Ability to organize effective record keeping and information retrieval.
• Demonstrates ability to coordinate and organize complex technical meetings.
• Ability to maintain confidentiality of information and records with tact and discretion.
• Ability to structure and provide training sessions.
• Minimum of 2 years' experience in pharmaceutical or medical device industry or a Master's degree.
• The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification.

EOE M/F/Disability/Vet