New · posted Nov 12
BeOne Medicines · Biotechnology
Director, Regulatory Affairs - US
- Remote, US
- Remote
- Full-time
- Director
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 Director, Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory strategies for development programs to secure and maintain market access in NA for product(s) in line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders. This individual will manage NA regulatory aspects of compounds through all phases of development, post-approval, and life cycle of the product. The incumbent will provide leadership and strategic regulatory oversight from a NA perspective for designated projects ensuring that the latest requirements and standards are met. Externally, the individual will interface with outside regulatory agencies and more specifically, the FDA, and business partners regarding development, regulatory, and registration strategies within the US and Canada. The Director will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.
What you need
Other Qualifications
- 10+ years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory capacity with a broad background
- Bachelor’s degree required; advanced degree preferred
- Preferred candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior experience with both small molecules and biologics
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments
- Strong business acumen and ability to make sound decisions that contribute positively to the business
- Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
- Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders
- Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion
- Strong negotiating skills and ability to think creatively and develop creative solutions
- Proven ability to build trust and respect within the organization
- Ability to prioritize and handle multiple projects simultaneously
- Interacts with external business partners and Regulatory Agencies
- Proven ability to build trust and respect within the organization.
- Ability to prioritize and handle multiple projects 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
- Provides high level regulatory strategic and operational direction for NA and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, regulatory strategic development plans and risk assessments, critical issue management and advice for the FDA and Health Canada interactions.
- Uses extensive knowledge of US, regulatory requirements and applies this knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
- Oversees the preparation and submission of documentation to support investigational and marketing registration packages within the US and Canada ensuring timelines are met in alignment with the global strategy as determined by the global regulatory leader.
- Reviews sections of the documents that will be utilized in the US and Canada in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
- Liaises and negotiates with the FDA and Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes
- Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation
- Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business
- Trains, develops, and manages an effective regional regulatory team both via direct and indirect reporting structure
- Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
- Manages critical issues, taking leadership for the regulatory contribution.
- Responsible for assisting with the development and implementation of regulatory processes
- Recruits, develops, manages, and mentors regulatory professionals and helps create a goal-oriented culture
Supervisory Responsibilities
Some supervisory responsibilities for multi-level regulatory team(s)
Computer Skills:
- Experience with Microsoft Office suite
- Veeva regulatory publishing
- PowerPoint presentation authoring and presentation
Pay and benefits
$176,000 – $236,000 a year
Employer providedSalary Range: $176,000.00 - $236,000.00 annually
Medical
Dental
Vision
401(k)
Paid Time Off
Employee Stock Purchase Plan
Working conditions
Travel
Business travel to be 10-20% as required
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 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% below the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Director roles in the US46 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $176,000 | — | $236,000 |
| All US (middle half) | $217,125 | $240,500 | $271,875 |
This role: BeOne Medicines's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 94 open Regulatory Strategy 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 48 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership18
- Documentation and SOPs3
- Regulatory submissions3
- Data and digital systems3
- Clinical trial conduct2
- GMP and compliance1
- Lab testing and methods1
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in biotechnology, led by the four this posting names, each linked to the agency or standards body that publishes it.
- 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
- 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)Named in the posting
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- 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
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- FDA21 CFR Part 1271(official source, opens in a new tab)Human cells, tissues, and cellular and tissue-based products
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
BeOne Medicines on Regulatory Jobs
- 47
- Open roles
- 47
- Distinct roles
- 2
- Locations
By discipline
- Clinical27 57%
- Regulatory12 26%
- Quality7 15%
By level
- Director18 38%
- Manager13 28%
- Senior & Principal10 21%
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Director, Regulatory Affairs - US at BeOne Medicines
Open until filled. $176K–$236K a year, employer provided.