[Hiring] Senior Associate, Regulatory Affairs @BeiGene

Role Description

The Senior Associate plans, tracks, and executes U.S. regulatory submissions to the FDA for investigational and commercial 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.

This role requires prior Regulatory Affairs experience, including hands‑on support of U.S. IND preparation and working knowledge of NDA submissions and related 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 lead and cross‑functional coordinator for assigned U.S. regulatory submissions, ensuring clarity 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-ready documents.
• Perform 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 integrity, and inspection readiness.
• Request FDA application numbers via the CDER NextGen Portal and support FDA correspondence tracking.
• Utilize regulatory tracking tools (e.g., Veeva Vault RIM, submission trackers) to monitor milestones, deliverables, and risks.
• Monitor FDA guidance updates and contribute to continuous improvement of US submission processes.

Qualifications

• BA/BS degree, preferably in a scientific or health‑related 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 Adobe Acrobat Professional.
• Understanding of FDA structure and working knowledge of FDA and ICH regulatory guidance and regulations is desirable.
• Demonstrates sound judgment and practical business awareness in supporting regulatory activities and execution decisions.
• Demonstrates ability to function as a trusted cross‑functional partner in a matrixed regulatory environment.
• The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
• Clear written and verbal communication with cross-functional teams.
• Strong organizational and documentation skills.
• Ability to manage multiple US submissions and priorities simultaneously.

Requirements

• 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.

Benefits

• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards.
• Participation in the annual bonus plan for Non-Commercial roles and an incentive compensation plan for Commercial roles.

Company Description

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act 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].