New · posted Nov 6
BeOne Medicines · Biotechnology
Senior Associate, Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
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.
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.
What you need
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
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.
What you'll do
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
Pay and benefits
$93,600 – $123,600 a year
Employer providedSalary Range: $93,600.00 - $123,600.00 annually
Medical
Dental
Vision
401(k)
FSA/HSA
Paid Time Off
Working conditions
Travel: N/A
Equal opportunity, accessibility and legal noticesBeOne Medicines's statements, word for word
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. 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].
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 12% below the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Senior & Principal roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $93,600 | — | $123,600 |
| All US (middle half) | $117,125 | $123,500 | $135,875 |
This role: BeOne Medicines's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 40 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not BeOne Medicines's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 49 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions20
- Collaboration and leadership12
- Documentation and SOPs9
- GMP and compliance5
- Data and digital systems4
- Investigations and CAPA2
- Lab testing and methods1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Operations work in biotechnology, led by the four this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissionsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLANamed in the posting
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- FDAFDA Structured Product Labeling(official source, opens in a new tab)The SPL standard for submitting labeling content to FDA
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
BeOne Medicines on Regulatory Jobs
- 42
- Open roles
- 42
- Distinct roles
- 2
- Locations
By discipline
- Clinical22 52%
- Regulatory11 26%
- Quality8 19%
By level
- Director18 43%
- Manager10 24%
- Senior & Principal10 24%
More roles at BeOne Medicines
- View role
Director, GCO Clinical Program Lead (GCPL)
Remote, USDirectorBiotechnology$172K–$232K
- View role
Executive Director, Head of Clinical Operations Excellence
Remote, USVP & ExecutiveBiotechnology$272K–$352K
- View role
Director, GCP Inspection Management - Americas
Remote, USDirectorBiotechnology$172K–$232K
- View role
Director, Safety Scientist
Remote, USDirectorBiotechnology$185K–$245K
Similar Regulatory Operations roles elsewhere
- View role
Senior Expert, Regulatory Affairs Operations
Bavarian NordicRemote, US, East Coast preferredSenior & PrincipalBiotechnology$120K–$160K
Senior Associate, Regulatory Affairs at BeOne Medicines
Open until filled. $94K–$124K a year, employer provided.