General 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 cross0functional stakeholders to ensure submissions are delivered accurately, on time, and in compliance with FDA requirements.

The role assumes end0to0end execution responsibility for assigned U.S. submissions and requires strong communication skills, exceptional organizational discipline, and a proactive, hands0on mindset, as well as the ability to operate as a flexible, collaborative team player who is open to learning and adapting in a fast0paced, deadline0driven environment.

This role requires prior Regulatory Affairs experience, including hands0on support of U.S. IND preparation and working knowledge of NDA submissions and related amendments or supplements; it is not an entry0level 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 cross0functional 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 on0time, first0cycle0quality 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.
  

Supervisory Responsibilities:

• None
  

Computer Skills:

• 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.

• Proficiency in Microsoft Office.
  

Other Qualifications:

• BA/BS degree, preferably in a scientific or health0related discipline OR 3+ years of Regulatory Affairs experience, including hands0on 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.

• Assist regulatory affairs team/strategist in supporting strategies 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 decisions.

• Demonstrates ability to function as a trusted cross0functional 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.

• Hands0on, execution0driven mindset with accountability for deliverables and outcomes.

• 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

When we exhibit our values of Patients First, Driving Excellence, Bold 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 Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

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. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees 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, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.