Regulatory Affairs Lead

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 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 ) for more information and to see all current openings.

The Job

As a Regulatory Affairs Lead with QPS (a full-service, global Contract Research Organization), you will lead regulatory strategies and submission activities for sponsor clients across multiple therapeutic areas, with a focus on U.S. FDA submissions. You will oversee regulatory deliverables, collaborating with internal teams and sponsor stakeholders to ensure high-quality, compliant submissions that meet all applicable health authority requirements.

Key Responsibilities:

• Serve as the primary regulatory lead on sponsor projects, advising on and implementing submission strategies for INDs, NDAs, amendments, and other FDA-regulated filings.
• Manage and coordinate the preparation, review, and timely submission of regulatory documents to the FDA and other U.S. health authorities.
• Participate in regulatory authority meetings (e.g., Pre-IND, Type B/C) and assist sponsors with briefing package development and logistical planning.
• Provide expert guidance to internal teams and sponsor clients on ICH and FDA regulatory frameworks, including CFR and GCP requirements.
• Collaborate cross-functionally with Clinical Operations, CMC, Pharmacovigilance, and Medical Writing to ensure cohesive and high-quality submission content.
• Maintain awareness of changes in regulatory requirements and provide proactive communication and strategic recommendations to internal and external stakeholders.
• Support business development by contributing to proposals, capabilities presentations, and bid defense meetings requiring regulatory input.

Work Location

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

Requirements

• Bachelor's degree in life sciences, pharmacy, or a related field (advanced degree preferred).
• 5–8 years of regulatory affairs experience, with at least 3 years in a CRO or client-service environment.
• Demonstrated experience with FDA regulatory submissions (e.g., IND, NDA) in eCTD format.
• Strong understanding of ICH, GCP, and FDA regulatory frameworks.
• Excellent project management and communication skills, with the ability to manage multiple sponsor relationships and competing priorities.
• Experience leading regulatory meetings with clients and/or FDA representatives.
• Proficiency with document management systems and submission platforms (e.g., Veeva Vault, GlobalSubmit, or similar).
• Regulatory Affairs Certification (RAC) or equivalent is a plus.

Preferred experience includes:

• Exposure to oncology, rare disease, or biologics development programs.
• Experience supporting early-phase clinical trials through to registration.Prior involvement in orphan drug designations or expedited programs (e.g., Fast Track, Breakthrough Therapy).
• Ability to work effectively across time zones and in a fast-paced, deadline-driven CRO environment.

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.  

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