Senior Associate, Regulatory Affairs - US

BeiGene

1d•$93,600 - $123,600

About The Position

The Senior Associate, Regulatory Affairs plans, tracks, and executes U.S. regulatory submissions to the FDA for investigational and commercial products. The role supports IND, NDA, and BLA filings and serves as an operational liaison among U.S. Regulatory Strategy, Regulatory Publishing, and cross-functional stakeholders to ensure submissions are accurate, timely, and compliant with FDA requirements. The position has end-to-end execution responsibility for assigned U.S. submissions. It 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. The role is not entry-level and calls for strong communication, organization, a proactive hands-on approach, and the ability to collaborate and adapt in a fast-paced, deadline-driven environment.

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 required hands-on support of U.S. IND preparation.
Prior Regulatory Affairs experience; this is not an entry-level position.
At least 3 years of direct experience preparing and executing FDA submissions (IND, NDA, BLA) and lifecycle management activities.
Working knowledge of NDA submissions and related amendments or supplements.
Experience with CTD/eCTD.
Experience publishing documents using Adobe Acrobat Professional.
Familiarity with regulatory systems such as Veeva Vault BRIM and document management tools.
Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
Ability to manage submission timelines, trackers, and Master Document Lists.
Strong written and verbal communication skills for working with cross-functional teams.
Strong organizational and documentation skills, attention to detail, and ability to manage multiple U.S. submissions and priorities simultaneously.
Ability to work independently and collaboratively under tight FDA-driven timelines.
Hands-on, execution-driven mindset with accountability for deliverables and outcomes.
Ability to function as a trusted cross-functional partner in a matrixed regulatory environment.
Sound judgment and practical business awareness in supporting regulatory activities and execution decisions.

Nice To Haves

Understanding of FDA structure and working knowledge of FDA and ICH regulatory guidance and regulations.
Experience in a fast-paced, entrepreneurial environment and willingness to learn and adapt.

Responsibilities

Coordinate preparation and execution of U.S. regulatory submissions, including INDs, NDAs, BLAs, amendments, and supplements, in compliance with FDA regulations and guidance.
Draft regulatory submission documents, including IND components, as required.
Review regulatory documentation for accuracy, consistency, and completeness, and support effective execution of submissions to health authorities.
Lead execution and cross-functional coordination for assigned U.S. submissions, clarifying roles, timelines, and deliverables.
Partner with U.S. Regulatory Strategists to translate regulatory plans into submission timelines and deliverable strategies.
Work with Clinical, CMC, Safety, Nonclinical, Medical Writing, and Labeling teams to collect and organize FDA submission-ready documents.
Perform quality-control checks for accuracy, consistency, and compliance with eCTD technical specifications and FDA requirements.
Liaise with Regulatory Publishing to support timely, first-cycle-quality FDA submissions.
Maintain IND, NDA, and BLA submission archives, including version control, document integrity, and inspection readiness.
Request FDA application numbers through the CDER NextGen Portal and support FDA correspondence tracking.
Use regulatory tracking tools, such as 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.
Assist the regulatory affairs team and strategists in supporting strategies for the earliest possible approvals or clearances of submissions associated with assigned projects.
Manage preparation, writing as necessary, assembly, review, and timely submission of regulatory dossiers for product investigation and registration in the U.S. and abroad.