Clinical Regulatory Specialist 6/29/2018

US WorldMeds Louisville, KY

Louisville, KY
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)
Bachelors Degree



Supports clinical regulatory department with cross-functional projects, submission requirements, and specific regulatory and development initiatives as required.

The following reflects management s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons:

* Serves as the RA representative on project teams, as assigned.

* Capable of independent leadership for projects as assigned.

* Acts as a final, independent reviewer and approval signatory for regulatory packages ( green light packages ) collected from clinical study sites in advance of study drug shipment/site activation

* Participates in protocol development process to ensure alignment to target product profile (when applicable) and/or incorporation of regulatory body input/advice and relevant guidance documents within study design

* Leads preparation and cross-functional review of content for cover letters, relevant background and any questions for regulatory bodies to accompany new protocols, protocol amendments, meeting briefing packages, clinical information requests and amendments, and other clinical related submissions (e.g. statistical analysis plans, special protocol assessment requests) to the company s regulatory applications (e.g. INDs, NDAs, as applicable) and assures integrity of all related submissions

* Leads preparation of content for responses to FDA clinical requests for information.

* Assists with annual Investigator Brochure reviews/updates and submissions to the IND under the direction of the Senior Medical Director, incorporating support of clinical operations, medical, and medical writing teammates

* Prepares clinical sections for new or amended product labeling to ensure accuracy of data from referenced studies and accuracy of conclusions as supported by individual or integrated reports

* Assists the PM in assessing compliance for the conduct of clinical studies via adherence to USWM SOPs, GCP and FDA regulations

* Develops and maintains working knowledge of regulations/guidances/regulatory landscape for focus area

* Supports the project manager for focus area related initiatives (e.g. coordinating internal and external review of regulatory initiatives) as required to include vendor evaluation (e.g. consulting groups, KOLs, Advisory Committees, GCP auditors, etc.), coordination of contracting, timelines, budgeting, internal/external meeting management for projects/ sub-projects to support data generation necessary to filing objectives

* Leads in preparation of submissions (or applicable sections thereof) with clinical focus area content prior to transmittal to regulatory bodies

* Assists submissions personnel in maintenance of Regulatory Affairs documentation, as required.

* Supports assembling of content for periodic reporting requirements to include marketing application annual reports and investigational new drug annual reports under the direction of regulatory lead personnel.

* Researches and compiles data for regulatory department as requested

* Effectively communicates regulatory requirements within project teams so that scope, timelines and budgets can be assembled accordingly.

* Independently develop project timelines and budgets as required.

* Trains on and maintains responsibility for other regulatory department duties as assigned (e.g. assistance with preparation of state pharmacy board license applications, assistance with upkeep of regulatory budget tracking, and/or department invoice coding).


* Bachelor's Degree in Life or Engineering Science required

* Master's or PhD in science or medical related degrees desirable

* Good writing and strong organizational skills required.

* Demonstrated communication and human relation skills.

US WorldMeds' is an equal opportunity employer. US WorldMeds' does not discriminate in any aspect of its employment opportunities or practices on the basis of race, religion, gender, national origin, age, disability, or any other characteristic protected by law.