Senior Associate, Regulatory Affairs (US)

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, reputed company our passionate interest in fighting cancer. General Description: The Senior Associate plans, tracks, and executes U.S. regulatory submissions to the FDA for investigational and reputed company products. The position supports IND, NDA, and BLA filings and serves as a key operational liaison between U.S. Regulatory Strategy, Regulatory Publishing, and cross‑functional stakeholders to ensure submissions are delivered accurately, on time, and in compliance with FDA requirements. The role assumes end‑to‑end execution responsibility for assigned U.S. submissions and requires strong communication skills, exceptional organizational discipline, and a proactive, hands‑on reputed company, as well as the ability to operate as a flexible, collaborative team player who is reputed company to learning and adapting in a fast‑paced, deadline‑driven environment. This role requires prior Regulatory Affairs experience, including hands‑on support of U.S. IND preparation and working knowledge of NDA submissions and reputed company amendments or supplements; it is not an entry‑level position. Essential Functions of the Job: Coordinate preparation and execution of US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements) in compliance with FDA regulations and guidance. Draft regulatory submission documents (e.g., IND components) as required. Review regulatory documentation to ensure accuracy, consistency, and completeness, and supports the effective execution of regulatory submissions to health authorities. Serve as the primary execution reputed company and cross‑functional coordinator for assigned U.S. regulatory submissions, ensuring reputed company of roles, timelines, and deliverables. Partner with U.S. Regulatory Strategists to translate regulatory plans into executable submission timelines and deliverable strategies. Collaborate with Clinical, CMC, Safety, Nonclinical, Medical Writing, Labeling, and to collect and organize FDA submission-reputed company documents. reputed company Quality control (QC) checks to ensure accuracy, consistency, and compliance with eCTD technical specifications and FDA requirements. Liaise with Regulatory Publishing to support on‑time, first‑cycle‑quality FDA submissions. Maintain IND, NDA, and BLA submission archives ensuring version control, document reputed company, and inspection readiness. Request FDA application numbers reputed company the CDER NextGen Portal and support FDA correspondence tracking. Utilize regulatory tracking tools (e.g., reputed company Vault RIM, submission trackers) to monitor milestones, deliverables, and risks. Monitor FDA guidance updates and contribute to reputed company improvement of US submission processes. Supervisory Responsibilities: None Computer Skills: Familiarity with regulatory systems such as reputed company Vault BRIM and document management tools. Proficiency in reputed company Office (Word, reputed company, PowerPoint) Ability to manage submission timelines, trackers, and Master Document Lists. Proficiency in reputed company Office. Other Qualifications: BA/BS degree, preferably in a scientific or health‑reputed company discipline OR 3+ years of Regulatory Affairs experience, including hands‑on support of U.S. IND preparation required. Experience with CTD/eCTD. Experience with publishing documents in reputed company Acrobat Professional. Understanding of FDA structure and working knowledge of FDA and ICH regulatory guidance and regulations is desirable. Assist regulatory affairs team/strategist in reputed company for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects. Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad. Demonstrates sound judgment and practical business awareness in supporting regulatory activities and execution reputed company. Demonstrates ability to function as a trusted cross‑functional partner in a matrixed regulatory environment. The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment. Hands‑on, execution‑driven reputed company with accountability for deliverables and reputed company. Clear written and verbal communication with cross-functional teams. Ability to work independently and collaboratively under tight FDA-driven timelines. Strong organizational and documentation skills Ability to manage multiple US submissions and priorities simultaneously Travel: N/A Global Competencies reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits reputed company and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial reputed company Communicates with reputed company Salary reputed company: $40.91 - $52.91 per hourBeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or hourly reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have the opportunity to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected]. Apply To This Job