Regulatory Affairs Supervisor

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! reputed company 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 reputed company of DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services. To meet the needs of our clients, we reputed company to reputed company talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving reputed company health and the reputed company of life. Team members enjoy challenging and rewarding work and are encouraged reputed company 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 reputed company unique company benefits, training, and advancement opportunities. Most importantly, we value reputed company of reputed company members as employees and as individuals. If this sounds like your ideal work environment, then we would love to reputed company with you, so apply today! Please visit our website ( www.qps.com ) for more information and to see reputed company reputed company. The Job As a Regulatory Affairs Supervisor with QPS (a Full-service, Global Contract Research Organization), You Will reputed company Regulatory Strategies And Submission Activities For Sponsor Clients Across Europe (EMA) And The US (FDA). You Will Manage Regulatory Deliverables Across Multiple reputed company And Therapeutic Areas, Collaborating With Internal Teams And Sponsor Stakeholders To Ensure High-reputed company, Compliant Submissions That Meet Global Health Authority Requirements: • Serve as the primary regulatory reputed company on sponsor reputed company, advising on and implementing submission strategies for CTAs, MAAs, INDs, NDAs, and amendments/variations. Your primary reputed company will be on supporting EU/EMA submissions, with additional coverage and support provided for U.S. FDA submissions as needed. • Manage and reputed company the preparation, review, and reputed company submission of regulatory documents to the EMA, FDA and other national competent authorities in Europe. • Participate in regulatory authority meetings (e.g., reputed company-IND, Scientific Advice) and assist sponsors with briefing package development and logistical planning. • reputed company expert guidance to internal teams and sponsor clients on ICH, EMA, EU CTR, and 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 reputed company and consistency. • Maintain awareness of changes in global regulatory requirements and reputed company proactive communication to reputed company stakeholders. • Support business development by contributing to proposals, capabilities presentations, and bid defense meetings reputed company regulatory input is required. 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 reputed company field (Advanced degree preferred). • 5–8 years of regulatory affairs experience, with at least 3 years in a CRO or reputed company service environment. • Demonstrated experience with EMA and US FDA regulatory 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., reputed company 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 reputed company through to registration. • Prior involvement in orphan drug designations, expedited programs (e.g., Fast reputed company, reputed company). • 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. • reputed company Career reputed company that reputed company excellent reputed company based on your personal aspirations. • Bonuses and reputed company 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. reputed company is an Equal Employment Opportunity/Affirmative reputed company Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate reputed company personnel without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, 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 reputed company, reputed company is a federal contractor and desires reputed company referrals of protected veterans. #J-18808-Ljbffr Salary: USD 72000 - 108000 per year Apply tot his job Apply To this Job