BeOne Medicines

Associate Director, Regulatory Affairs, CMC

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

  • Serve as the regulatory CMC representative on project teams.
  • Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, Supply Chain and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers.
  • Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information.
  • Author and lead CMC content for Health Authority meeting briefing packages, including development of CMC strategy, preparation of CMC-related questions, supporting data summaries, and responses to Health Authority feedback, in collaboration with Global Regulatory and cross-functional teams.
  • Develop and implement effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and can interpret and apply local regulations and guidance’s to the life cycle of a drug product.
  • Actively participate as a member of global regulatory teams and CMC subteams.
  • Support and manages regulatory aspects of CMC Operations including authoring, reviewing and or approving SOP’s, CAPA’s, etc.

Requirements

  • Minimum 8+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in development products and commercial product lifecycle including Phase 1-3, and marketed products)
  • BS/BA Biochemistry, Biology, or Pharmaceutical Science; Advanced degree preferred.
  • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint), Veeva Data Management System
  • Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
  • Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including FDA and other Health Authorities.
  • Demonstrated ability to coach, train and mentor teams.
  • Strong negotiating skills and ability to think creatively and develop creative solutions.
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
CMC regulatory supportbiologics expertisedrug product lifecycleclinical trial applicationsmarketing applicationsSOP authoringCAPA managementregulatory strategy developmentdata summaries preparationregulatory submissions
Soft Skills
collaborationcoachingmentoringnegotiationcreative problem solving