Senior Associate, Regulatory Affairs

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $93.6k - $123.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Plan, track, and execute U.S. regulatory submissions to the FDA for investigational and commercial products • Coordinate preparation and execution of INDs, NDAs, BLAs, amendments, and supplements • Draft regulatory submission documents, including IND components • Review regulatory documentation for accuracy, consistency, and completeness • Serve as primary execution lead and cross-functional coordinator for assigned U.S. submissions • Translate regulatory plans into executable submission timelines and deliverable strategies with U.S. Regulatory Strategists • Collect and organize FDA submission-ready documents with Clinical, CMC, Safety, Nonclinical, Medical Writing, and Labeling teams • Perform quality-control checks for eCTD technical specifications and FDA requirements • Liaise with Regulatory Publishing to support on-time, first-cycle-quality FDA submissions • Maintain IND, NDA, and BLA archives, version control, document integrity, and inspection readiness • Request FDA application numbers through the CDER NextGen Portal and track FDA correspondence • Use Veeva Vault RIM and submission trackers to monitor milestones, deliverables, and risks • Monitor FDA guidance updates and contribute to continuous improvement of U.S. submission processes • Support regulatory strategies for earliest possible approvals or clearances • Manage preparation, writing, assembly, review, and timely submission of regulatory dossiers in the U.S. and abroad

🎯 Requirements

• BA/BS degree, preferably in a scientific or health-related discipline, with 2+ years of experience OR 5+ years of Regulatory Affairs experience, including hands-on support of U.S. IND preparation (required) • 3+ years of direct experience preparing and executing FDA submissions (IND, NDA, BLA) and lifecycle management activities • Prior Regulatory Affairs experience; hands-on support of U.S. IND preparation and working knowledge of NDA submissions and related amendments or supplements • Experience with CTD/eCTD • Experience publishing documents in Adobe Acrobat Professional • Working knowledge of FDA and ICH regulatory guidance and regulations is desirable • Familiarity with regulatory systems such as Veeva Vault BRIM and document management tools • Proficiency in Microsoft Office (Word, Excel, PowerPoint) • Ability to manage submission timelines, trackers, and Master Document Lists • Strong organizational and documentation skills • Ability to manage multiple U.S. submissions and priorities simultaneously • Ability to work independently and collaboratively under tight FDA-driven timelines

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume