QPS Holdings, LLC

Regulatory Affairs Associate

No longer accepting applications

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you!

Join QPS’ Global Regulatory Affairs Team to support EU regulatory filings for our clients in the pharmaceutical, biologics and medical device industries .

QPS’ Story

Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.

Team members enjoy challenging and rewarding work and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, teamwork and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals.

If this sounds like your ideal work environment, then we would love to speak with you, so apply today!

Please visit our website ( www.qps.com ) for more information and to see all current openings.

The Job

You will work with our Global Regulatory Affairs (RA) team on European (EU) regulatory filings for our clients. Your essential functions include –

  • Preparing EU CTIS Regulatory dossier submissions
  • Working with Regulatory Affairs Specialist to prepare query responses in a timely manner
  • Digital filing of study-related documentation and correspondence
  • Completing document redactions on behalf of the sponsor
  • Staying actively informed and updated on EU guidance and regulation
  • Ensuring compliance with Good Clinical Practice (GCP) standards in all work activities

Work Location

This job will be 100% home-office based. (see Telecommuting Policy for full details)

Requirements

  • Combination of relevant education & experience that provides sufficient knowledge & skills to ensure incumbent’s success in this role, such as:
    • University/College Degree in relevant Scientific discipline, and/or
    • Demonstrated experience in CRO, Clinical Research, or other relevant field (ideally a minimum of 2 years in clinical research)
    • Candidates with less education, but with additional relevant work experience, will be considered
  • Demonstrated working knowledge of submissions to EU health authorities and Ethics Committees (specifically, experience with EU CTD submissions and a current understanding of regulatory guidance in the EU). Prior CTIS knowledge or experience strongly preferred
  • Excellent communication skills in English
  • Attention to detail and able to maintain GCP compliance standards
  • Analytical thinker with ability to be thorough and seeks key information before acting.
  • Has the ability to work independently and demonstrates accountability for actions and impact
Why You Should Apply

  • Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
  • Structured Career Ladders that provide excellent growth based on your personal aspirations.
  • Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
  • Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance
  • Park-like setting in Newark, Delaware
  • Internal committees designed with the needs and enjoyment of QPS employees in mind.

QPS, Holdings is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.
  • Seniority level

    Entry level
  • Employment type

    Full-time
  • Job function

    Legal
  • Industries

    Pharmaceutical Manufacturing

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