BeOne Medicines

Senior Director, Regulatory Affairs, CMC

BeOne Medicines

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $204,500 - $274,500 per year

Job Level

Senior

About the role

  • Lead and develop the U.S. Biologics Regulatory CMC team
  • Provide strategic and operational leadership for global biologics Regulatory CMC strategies
  • Partner closely with global cross-functional stakeholders on CMC regulatory strategies
  • Establish and continuously improve Regulatory CMC standard operating procedures (SOPs)
  • Ensure appropriate Regulatory CMC assessment throughout the product lifecycle
  • Review and approve Regulatory CMC documentation within the RIM system
  • Represent the company in external forums and regulatory or scientific conferences

Requirements

  • BA/BS Degree in scientific disciplines, MS/PhD preferred
  • 12+ years of relevant pharmaceutical or biopharmaceutical experience
  • At least 10 years of direct Regulatory CMC experience
  • Demonstrated track record of leading Health Authority interactions
  • Proven experience leading and developing teams of 10+ or more professionals
  • Advanced scientific training with hands-on expertise in at least one core pharmaceutical or biologics discipline
  • In-depth knowledge of ICH guidelines and global Regulatory CMC requirements
  • Extensive experience authoring, reviewing, and managing complex technical documentation
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 & Tools
Regulatory CMCpharmaceutical experiencebiopharmaceutical experiencetechnical documentationICH guidelinesglobal Regulatory CMC requirementsstrategic leadershipoperational leadershipSOP developmentHealth Authority interactions
Soft Skills
team leadershipcross-functional collaborationstrategic thinkingcommunicationproblem-solvingorganizational skillsstakeholder engagementmentoringdecision-makingpresentation skills
Certifications
BA/BS DegreeMS/PhD