Regulatory Affairs Specialist

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!
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, team work 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

• Remains current with regulatory intelligence and ensure submissions are aligned with current standards/expectations and local regulations
• Demonstrates expert knowledge of submissions to EU health authorities and Ethics Committees
• Experienced with EU submissions under the Clinical Trial Directive (CTD)
• Experienced with EU Clinical Trials Information System (CTIS) Submissions under the Clinical Trial Regulation (CTR)
• Partners with clients to support Regulatory Agency communications.
• Partners with Senior Regulatory Affairs and Project Manager internal professionals to deliver client submissions in a timely and efficient manner.
• Contact person for the EC and CA in the Netherlands (and other EU countries if and when applicable).
• Digital filing of study-related documentation and correspondence.
• Organization and coordination of Clinical Trial Application (CTA)
• Accurate and representative communication with Project Manager internal professionals, clients and authorities.
• Timely notification of projects to the authorities.
• Make final and approved documents available for project team members and/or external parties.
• Work GCP compliant.
  

Work Location

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

Requirements

• EU CTIS Regulatory dossier submissions
• Excellent communication skills in English
• The level of education should be at least Higher Vocational Education (in Dutch: HBO)
• Candidates with less education, but with relevant work experience, can be considered
• At least 3 years in administrative and coordinating activities
• GCP & CTR certified
  

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, LLC 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.