Regulatory Manager

Princeton, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a Regulatory Manager in Princeton, New Jersey.  The Regulatory Manager liaises with regulatory agencies in order to expedite approval of pending registration and answer questions, and ensures that clinical trial related regulatory documents meet regulatory requirements as designed. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

RESPONSIBILITIES

  • Provides support to Regulatory Lead on supplying guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines
  • Researches regulatory requirements and intelligence for clinical and pre-clinical submissions to FDA for assigned investigational and marketed products 
  • Prepares, reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards 
  • Provides support to Regulatory Lead in the provision of appropriate regulatory guidance to Project Teams for the development of the above regulatory submissions
  • Works collaborative with other Regulatory managers both within and across projects

EXPERIENCE

  • At least 2 years of pharmaceutical industry experience in regulatory affairs
  • Knowledge of clinical trial management and transfer of sponsor obligations; the drug development, approval and post marketing product processes
  • Understanding of roles and responsibilities of individuals within the project team, SOPs and GCP/ICH regulations; of medical concepts and terminology, including strong knowledge of FDA Part 11 and global regulations.
  • Knowledge of CFRs, ICH and FDA regulations

EDUCATION

  • PharmD, PhD or 
  • Bachelor of Science Degree with minimum 3 to 5 years of experience

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