Senior Associate, Regulatory Affairs - US

BeOne Medicines USA, Inc.

United States

Remote

USD 94,000 - 124,000

Full time

6 days ago

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Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. is seeking a Senior Associate Regulatory Affairs to manage U.S. submissions (INDs, NDAs, BLAs) for investigational and commercial products. You will coordinate cross-functional teams, ensure FDA compliance, and drive submissions to on-time completion.

The ideal candidate has hands-on U.S. IND experience, proficiency with eCTD, and strong communication. BeOne offers a comprehensive benefits package and a path to equity, with a collaborative, fast-paced environment.

Qualifications

Hands-on experience with U.S. IND preparation.
Experience with NDA/BLA submissions.
Familiarity with FDA guidance and ICH regulations.

Responsibilities

Coordinate US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements) in compliance with FDA regulations.
Draft regulatory submission documents (e.g., IND components) as required.
Review regulatory documentation for accuracy, consistency, and completeness.
Serve as primary execution lead and cross-functional coordinator for assigned submissions.
Collaborate with Regulatory Strategy and cross-functional teams to gather submission-ready documents.
Perform QC checks to ensure FDA submission readiness and document integrity.
Maintain IND, NDA, BLA submission archives with version control.

Skills

Regulatory systems (Veeva Vault BRIM)

MS Office suite (Word, Excel, PowerPo

Submission timelines management

Cross-functional collaboration

Education

BA/BS degree in science or health-related discipline

Tools

Adobe Acrobat Pro

CTD/eCTD workflows

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share 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 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. 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 mindset, as well as the ability to operate as a flexible, collaborative team player who is open 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 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.

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.

Education & Experience Required

BA/BS degree, preferably in a scientific or health‑related discipline with 2+ years OR 5+ year of Regulatory Affairs experience, including hands‑on support of U.S. IND preparation (required)

Other Qualifications

3+ years of direct experience preparing and executing FDA submissions (IND, NDA, BLA) and lifecycle management activities.
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 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 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

Salary Range

Salary Range: $93,600.00 - $123,600.00 annually 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.

Benefits

The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

EEO Statement

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. All employment is decided on the basis of qualifications, merit, and business need.

Accommodations

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 accommodationsus@beonemed.com.