BeOne Medicines

Associate Director, Regulatory CMC – Small Molecule

BeOne Medicines

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $142,000 - $192,000 per year

Job Level

Senior

About the role

  • Manage, evaluate, and complete regulatory projects consistent with company goals
  • Lead, develop and implement small molecule CMC regulatory strategies
  • Authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions
  • Develop regulatory strategy and execute in the preparation of timely responses
  • Work collaboratively with cross-functional leads and communicates CMC regulatory strategies
  • Lead regulatory risk assessment, identify key CMC regulatory issues
  • Provide CMC regulatory review for clinical protocols and investigator brochures for the assigned project

Requirements

  • 8+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience
  • BA/BS Degree in scientific disciplines, MS/PhD preferred
  • Proven record of leading Health Authority interactions
  • In-depth knowledge of ICH requirements and US/EU regulatory requirements
  • Knowledge/experience with regulatory requirements for rest of world regions and GMP regulation is a plus
  • Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management
  • Excellent oral and written communications skills are a must-have
  • Detail-oriented, self-motivated, and comfortable with broad responsibilities
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 CMC experienceauthoring CTD CMC sectionsregulatory strategy developmentregulatory risk assessmentauthoring complex technical documentsCTD M2 sectionsCTD M3 sectionslife cycle managementGMP regulation
Soft Skills
leadershipcollaborationcommunicationdetail-orientedself-motivated
Certifications
BA/BS DegreeMS/PhD