Beigene

Beigene

Associate Director, Global Regulatory Project Management

Remote (US) · Director

Sponsorship not specified$147k-$197kDetected 28 days ago
Data AnalysisData VisualizationProject ManagementNegotiationExcelProcess ImprovementLeadershipCommunicationCollaborationProblem SolvingMentoringMicrosoft Office

About 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.
  • General Description: The Associate Director, Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and executing regulatory strategies across the global drug development lifecycle.

Responsibilities

  • Guiding and developing junior team members to support their growth and long-term success within the organization.
  • 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.
  • 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.
  • Liaise and negotiate with cross-functional teams to expedite submission timelines and support resolve key regulatory issues in all relevant markets.

Requirements

  • 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.
  • Proficiency with project management and document management tools (e.g., Smartsheets, MS Project, Power BI, MS Office suite).
  • Occasional international and domestic travel may be required to support global project teams, attend regulatory meetings, or participate in industry conferences.
  • Excellent verbal and written communication skills; able to understand and translate complex regulatory issues clearly to internal and external stakeholders worldwide.

Nice to have

  • Bachelor's degree in Science or related discipline
  • advanced degree preferred.

Skills

  • Advanced skills in the Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
  • Ability to quickly learn and adapt to new software platforms and digital collaboration tools.
  • Other Qualifications Experience:
  • Bachelor's degree in Science or related discipline; advanced degree preferred.
  • 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.
  • Skilled in conflict resolution, negotiation, and fostering open communication across cultures.
  • PMP or similar certification preferred.
  • Key Attributes:
  • Proactive, not reactive; anticipates challenges and takes initiative to address them.
  • Demonstrates integrity, accountability, and strategic leadership.
  • Able to balance multiple tasks, prioritize effectively, and meet deadlines across time zones and regions.

Compensation

  • $146,700.00 - $196,700.00 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.
  • 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.

Benefits

  • 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.).
  • 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.

Company info

  • Thrives in a global team environment and seeks excellence as the measure of success.
  • 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.

Equal opportunity

  • We are proud to be an equal opportunity employer.
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This listing is sourced directly from Beigene's careers page and normalized into a canonical job model.