BeOne Medicines

Associate Director – Global Regulatory Project Management

BeOne Medicines

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Salary

💰 $144,600 - $194,600 per year

Job Level

Senior

Tech Stack

PMP

About the role

  • Translate, implement, and advise on global regulatory strategies for development programs
  • Act as a key advisor to the GRL/RRL, providing strategic regulatory oversight and recommendations for global product development, submissions, and lifecycle management
  • 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
  • Organize and facilitate cross-functional meetings with global teams to coordinate, plan, and track submission activities
  • 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
  • Build partnerships with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC, commercial) across regions
  • Mentor and guide junior staff in project planning, regulatory processes, and professional development
  • Champion process optimization and improvement initiatives within the global regulatory PM function

Requirements

  • 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)
  • PMP or similar certification preferred.
Benefits
  • Medical
  • Dental
  • Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory project managementregulatory submissionsstrategic regulatory leadershipsmall moleculesbiologicssubmission documentationprocess optimizationrisk managementdata integrationdecision-making
Soft skills
business acumenstrategic thinkingverbal communicationwritten communicationconflict resolutionnegotiationcross-cultural communicationmentoringteam leadershipstakeholder influence
Certifications
PMP