Clinical Regulatory Affairs Associate

North Chicago, IL

Contract

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OVERVIEW

At Advanced Clinical, we’re excited to share with you a great opportunity at for the position of Clinical Regulatory Affairs Associate in the northern suburbs of Chicago, Illinois. The Clinical Regulatory Affairs Associate interacts with multiple departments, as appropriate, involved in regulatory submissions. The position, under supervision of the manager, makes FDA submissions, reviews requisite and critical documents and reports for completeness and suitability for submission.

RESPONSIBILITIES

  • Receive documents from various sources and review for completeness and suitability for submission to FDA
  • Request missing or illegible pages, arrange for translations 
  • Review regulatory documents to assure FDA requirements are met and are ready for submission
  • Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies, including assuring the regulations and laws regarding IND submissions and financial disclosure meet compliance
  • Assure CMC and QA have approved the product, and that the labeling of the product meets the regulations for interstate shipment
  • Handle drug re-supplies for the above-mentioned studies
  • Prepare 30-day investigator submissions
  • Gather information and prepare IND and NDA annual reports
  • With the manager's guidance, prepares new IND, NDA and SNDA submissions, amendments and supplements

EXPERIENCE

  • 3 years of work experience
  • A basic understanding of scientific disciplines required
  • Understanding of FDA regulations governing INDs, NDAs, GCPs, submission processes, submission content, and specific time requirements for various submissions desired
  • Good computer skills required

EDUCATION

  • Bachelor’s of Science (biology, chemistry etc.) preferred

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

847-267-1176