BeOne
Global oncology therapeutics discovery, development, manufacturing
Associate Director - Global Regulatory Project Management
+ Annual bonus + Discretionary equity awards + Employee Stock Purchase Plan
Occasional international and domestic travel may be required.
About the job
- A Bachelor's degree in Science or a related discipline is required.
- At least 8 years of experience in regulatory project management and regulatory submissions, including experience with both small molecules and biologics and significant global exposure.
- Demonstrated strategic regulatory leadership and a proven record of successful submissions and regulatory project management accomplishments across multiple regions.
- Experience leading cross-functional and cross-regional teams and influencing senior stakeholders globally.
- Strong business acumen, strategic thinking, and the ability to integrate multiple sources of data for sound decision-making.
- Excellent verbal and written communication skills, with the ability to understand and clearly translate complex regulatory issues to internal and external stakeholders worldwide.
- Skill in conflict resolution, negotiation, and fostering open communication across cultures.
- Proficiency with project management and document management tools, including Smartsheets, Microsoft Project, Power BI, and the Microsoft Office suite.
- Ability to balance multiple tasks, prioritize effectively, and meet deadlines across time zones and regions.
- Occasional international and domestic travel may be required.
- Translate, implement, and advise on global regulatory strategies for development programs, ensuring alignment with business objectives across major regions.
- Advise the Global Regulatory Lead and Regional Regulatory Lead by providing strategic regulatory oversight and recommendations for global product development, submissions, and lifecycle management.
- Integrate regulatory expertise with business knowledge to solve complex problems and make sound organizational decisions globally.
- Monitor global regulatory environments, policy trends, and competitive landscapes, assess their impact, and adapt strategies accordingly.
- Lead and manage complex regulatory submissions, including investigational new drug, clinical trial application, new drug application, biologics license application, and marketing authorization application submissions, across multiple regions.
- Translate the strategic regulatory vision into actionable project plans, drive operational execution, and coordinate cross-functional activities as the chief operating officer to the Global Regulatory Lead.
- Organize and facilitate cross-functional meetings with global teams to coordinate, plan, and track submission activities and drive accountability and alignment.
- Identify risks, propose solutions, and manage critical issues related to global regulatory submissions and strategy.
- Oversee preparation and submission of documentation supporting investigational and marketing registration packages while ensuring global timelines and quality standards are met.
- Build partnerships with senior stakeholders and cross-functional teams across clinical, medical, safety, chemistry, manufacturing, and controls, and commercial functions across regions.
- Liaise and negotiate with cross-functional teams to expedite submission timelines and resolve key regulatory issues in relevant markets.
- Mentor and guide junior staff in project planning, regulatory processes, and professional development.
- Champion process optimization and improvement initiatives within the global regulatory project management function.
- Contribute to the development and implementation of regulatory processes and policies across regions.
- Oversee cross-functional project teams and coordinate activities across global stakeholders.
- Support regulatory meetings and industry conferences as needed.
- An advanced degree is preferred.
- Experience with electronic document management systems and regulatory submission platforms is preferred.
- Project Management Professional certification or a similar certification is preferred.
About the company
BeOne Medicines develops and commercializes cancer therapies for patients worldwide, focusing on hematologic cancers and solid tumors. Its products, including Brukinsa, are sold globally and supported by licensing partnerships, with internal R&D and clinical development driving a broad late-stage pipeline. BeOne differentiates itself by leveraging a large-scale clinical trial network and cost-efficient global drug development to achieve high margins while pursuing large-market indications. The company aims to expand into immunology and solid tumors while maintaining strong investment in R&D to make high-impact, accessible oncology treatments available in more than 45 countries.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Dongcheng District, China
Founded
2010
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Simplify's Take
What believers are saying
- August 25, 2026 FDA approval expanded TEVIMBRA in first-line HER2-positive gastroesophageal cancer.
- August 31, 2026 Phase 3 survival data strengthened ZIIHERA-containing regimens.
- Q2 2026 revenue hit $1.7 billion; management raised 2026 guidance to $6.8 billion.
What critics are saying
- BeOne accepted developed-market pricing parity and Medicaid rebates on future U.S. approvals.
- Zydus' BRUKINSA ANDA lawsuit targets patents; a 2034 composition patent remains the fortress.
- AbbVie's trade-secrets case over BGB-16673 still threatens the BTK-degrader franchise.
What makes BeOne unique
- BeOne built 35-plus assets and 93 trials across 1,100 U.S. sites by September 2026.
- BRUKINSA dominates revenue, with 2026 global sales above $1.2 billion quarterly.
- Hopewell, New Jersey gives BeOne U.S. manufacturing, R&D, and packaging capacity.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
401(k) Retirement Plan
Wellness Program
Paid Vacation
Growth & Insights and Company News
6 month growth
↑ 6%1 year growth
↓ -9%2 year growth
↓ -3%BeOne Medicines secured an exemption from Section 232 pharmaceutical tariffs through a voluntary agreement with the US government. The deal recognises over $1 billion in US manufacturing investment, including a $300 million expansion in Hopewell, New Jersey. The exemption protects BeOne from import duties on patented pharmaceuticals and ingredients. However, the company committed to pricing future FDA-approved medicines in line with other developed markets and participating in the Medicaid GENEROUS Model, which uses supplemental rebates. The Hopewell expansion will add small-molecule manufacturing and packaging capacity, creating approximately 120 full-time jobs. The facility will support a portfolio of more than 35 assets. Whilst the tariff exemption reduces supply-chain risk, international reference pricing commitments could limit pricing flexibility for future oncology medicines. Neither the tariff savings nor the financial impact of pricing concessions was disclosed.
Revolution Medicines has partnered with BeOne Medicines in a multi-part collaboration combining BeOne's oncology assets with Revolution's four clinical RAS(ON) inhibitors. The August 2026 deal grants BeOne exclusive development and commercialisation rights in select Asian markets and commits BeOne to fund a global Phase 3 trial. Revolution Medicines reported a net loss of $644.37 million in Q2 2026 and $1.1 billion over six months. The company currently generates no revenue but projects $2.3 billion in revenue and $402.5 million in earnings by 2029. The partnership shifts near-term risk by offloading Phase 3 costs whilst providing access to milestone and royalty potential. However, the core investment case remains unchanged: regulatory progress and commercialisation of daraxonrasib, with trial execution and spending presenting the biggest risks.
BeOne Medicines reported second-quarter revenue of $1.7 billion, up 30% year over year, with GAAP earnings per ADS rising 144% to $2.05. The company's BTK inhibitor BRUKINSA generated more than $1.2 billion in global sales, increasing 31% from the prior year. The company raised its 2026 revenue guidance to CNY 6.6 billion–CNY 6.8 billion and expects GAAP operating income of CNY 1 billion–CNY 1.1 billion. Free cash flow doubled year over year to CNY 435 million. BeOne received FDA approval for Beqalzi in relapsed or refractory mantle cell lymphoma and reported positive Phase III results for a chemotherapy-free BRUKINSA regimen. US BRUKINSA sales totalled $893 million, up 31%, driven by demand in chronic lymphocytic leukaemia and non-CLL indications.
John Oyler, chief executive officer of BeOne Medicines AG, sold 109,713 American Depositary Shares worth $34.6 million on 20 and 21 July 2026, according to SEC filings. The transactions were executed under a Rule 10b5-1 trading plan adopted in March 2026. Despite the sale, Oyler retains a substantial ownership position exceeding 50.4 million total shares through various holdings. These include 28.2 million shares held through Oyler Investment LLC and 9.5 million shares in a Roth IRA account. The shares were sold at a weighted average price of $315.28. BeOne Medicines is a commercial-stage oncology biopharmaceutical company with $5.7 billion in trailing twelve-month revenue and a market capitalisation of $34.2 billion.
Seegene USA has received Emergency Use Authorization from the FDA for its Allplex HSV-1&2/VZV/MPXV Assay, a multiplex real-time PCR test that simultaneously detects herpes simplex virus types 1 and 2, varicella-zoster virus, and monkeypox virus. It is the first multiplex PCR test designed to support differential diagnosis of viral causes of ulcerative skin lesions in the US market. These pathogens often present with similar clinical symptoms that are difficult to distinguish visually. Research presented at the 2024 Clinical Virology Symposium found that a multiplex PCR assay identified HSV, VZV, or MPXV in 54 out of 966 samples that had previously tested negative using single-pathogen methods. The assay was developed using Seegene's proprietary multiplex PCR technologies and automated product development platform.