Regulatory Affairs Supervisor
Regulatory Affairs Supervisor
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Job Description
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 LLC has an opening for a Regulatory Affairs Supervisor!
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 Supervisorwith QPS (a full-service global Contract Research Organization) you will lead regulatory strategies and submission activities for sponsor clients across Europe (EMA) and the US (FDA). You will manage regulatory deliverables across multiple projects and therapeutic areas collaborating with internal teams and sponsor stakeholders to ensure high-quality compliant submissions that meet global health authority requirements:
- Serve as the primary regulatory lead on sponsor projects advising on and implementing submission strategies for CTAs MAAs INDs NDAs and amendments/variations. Your primary focus will be on supporting EU/EMA submissions with additional coverage and support provided for U.S. FDA submissions as needed.
- Manage and oversee the preparation review and timely submission of regulatory documents to the EMA FDA and other national competent authorities in Europe.
- Participate in regulatory authority meetings (e.g. Pre-IND Scientific Advice) and assist sponsors with briefing package development and logistical planning.
- Provide expert guidance to internal teams and sponsor clients on ICH EMA EU CTRand FDA CFR guidelines.
- Collaborate cross-functionally with Clinical Operations CMC Pharmacovigilance and Medical Writing to ensure cohesive submission content.
- Supervise or mentor junior regulatory team members reviewing their work for quality and consistency.
- Maintain awareness of changes in global regulatory requirements and provide proactive communication to internal and external stakeholders.
- Support business development by contributing to proposals capabilities presentations and bid defense meetings when regulatory input is required.
Work Location
This job will be 100% home-office based. (see Telecommuting Policy for full details)
Requirements
- Bachelors degree in life sciences pharmacy or related field (Advanced degree preferred).
- 58 years of regulatory affairs experience with at least 3 years in a CRO or client service environment.
- Demonstrated experience with EMA and US FDAregulatory submissions (e.g. CTA MAA IND NDA) including eCTD format.
- In-depth knowledge of global regulatory frameworks including ICH GCP EU Clinical Trial Regulation (CTR) and US FDA regulations.
- Strong project management and communication skills with the ability to manage multiple sponsor relationships and competing deadlines.
- Experience leading regulatory meetings with clients and/or health authorities.
- Proficiency with document management systems and submission platforms needed (e.g. Veeva Vault GlobalSubmit Extedo). Experience with CTIS is especially needed.
- 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 expedited programs (e.g. Fast Track PRIME).
- Comfortable working 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 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 addition QPS LLC is a federal contractor and desires priority referrals of protected veterans.
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Required Experience:
Manager
Employment Type
Full-Time
