Regulatory Affairs Specialist IV

Swiftwater, PA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Regulatory Affairs Specialist IV in Swiftwater, Pennsylvania. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity

RESPONSIBILITIES

  • Candidate to author technical documents in client’s internal documentum system
  • Must have working knowledge of bacterial biologics and regulations pertaining to pre and post licensure activities related to CMC
  • Must have working knowledge of GMPs
  • Must be well-organized, work with minimal management and meet aggressive timelines
  • Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality

EXPERIENCE

  • Minimum of 3 years of experience working with CMC
  • Minimum 3 to 6 years of prior experience with regulatory
  • Experience with drugs/biologics licensure
  • Experience with ICH guidelines and GMP experience
  • Technical writing experience
  • Scientific background

EDUCATION

  • Minimum of Bachelor’s Degree in Biology, Chemistry, or related field

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

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