BeiGene · 18 hours ago
Associate Director, Global Regulatory Project Management
United States
Full-time
Remote
Lead/Staff, Director/Executive
$145K/yr - $195K/yr
8+ years expBeOne Medicines USA is a rapidly growing company focused on fighting cancer. They are seeking an Associate Director, Global Regulatory Project Management to lead regulatory strategies and manage submissions across the global drug development lifecycle, ensuring compliance and cross-functional integration.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Translate, implement, and advise on global regulatory strategies for development programs, ensuring alignment with business objectives and long-term vision across all major regions (US, EU, China, APAC, LATAM, etc.)
Act as a key advisor to the GRL/RRL, providing strategic regulatory oversight and recommendations for global product development, submissions, and lifecycle management
Integrate functional expertise with business knowledge to solve complex problems and make sound decisions for the organization on a global scale
Maintain awareness of global regulatory environments, policy trends, and competitive landscapes, assessing impact and adapting strategies accordingly
Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across multiple regions, ensuring compliance with ICH, US, EU, China, and other international requirements
Act as the (COO) to the Global Regulatory Lead, translating strategic regulatory vision into actionable project plans, driving operational execution, and ensuring all cross-functional activities are coordinated and delivered on time
Organize and facilitate cross-functional meetings with global teams to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders worldwide
Proactively identify risks, propose solutions, and manage critical issues related to global regulatory submissions and strategy
Oversee preparation and submission of documentation to support investigational and marketing registration packages, ensuring timelines and quality standards are met globally
Build partnerships with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC, commercial) across regions to achieve strategic business goals through knowledge sharing and collaboration
Liaise and negotiate with cross-functional teams to expedite submission timelines and support resolve key regulatory issues in all relevant markets
Mentor and guide junior staff in project planning, regulatory processes, and professional development, fostering a global mindset
Champion process optimization and improvement initiatives within the global regulatory PM function
Contribute to the development and implementation of regulatory processes and policies, fostering a culture of excellence and innovation across regions
May provide direct or indirect supervision to regulatory project management staff, including mentoring, coaching, and professional development
Responsible for guiding junior team members and supporting their growth within the organization
May oversee cross-functional project teams and coordinate activities among global stakeholders
Acts as a leader and role model within the regulatory project management function, fostering a collaborative and high-performance culture
Qualification
Required
Bachelor's degree in Science or related discipline; advanced degree preferred
Minimum 8+ years of experience in regulatory project management and regulatory submissions, including both small molecules and biologics, with significant global exposure
Demonstrated experience in strategic regulatory leadership, with a proven track record of successful submissions and regulatory PM accomplishments in multiple regions
Experience leading cross-functional and cross-regional teams, influencing senior stakeholders globally
Strong business acumen, strategic thinking, and ability to integrate multiple sources of data for sound decision-making
Excellent verbal and written communication skills; able to understand and translate complex regulatory issues clearly to internal and external stakeholders worldwide
Skilled in conflict resolution, negotiation, and fostering open communication across cultures
Proficiency with project management and document management tools (e.g., Smartsheets, MS Project, Power BI, MS Office suite)
Preferred
Advanced degree preferred
PMP or similar certification preferred
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeiGene
BeiGene is a global oncology company.
0-1 employees
H1B Sponsorship
BeiGene has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (32)
2023 (39)
2022 (40)
2021 (28)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$6.79BKey Investors
Hillhouse InvestmentAmgen
2020-07-12Post Ipo Equity· $2.08B
2019-10-31Post Ipo Equity· $2.7B
2018-08-02Post Ipo Secondary· $903M
Leadership Team
Dirk Weber
Executive Director Medical Affairs (Europe)
Lai Wang
Global Head of Research and Development
Recent News
South China Morning Post
2025-12-20
Company data provided by crunchbase