Director, Regulatory Affairs CMC

Atlas Search is partnered with a growing Oncology Biotech that has an immediate need for a Director, Regulatory Affairs CMC to join their expanding team. They are seeking an experienced Reg CMC professional with a strong Oncology background to develop and lead the execution of Regulatory CMC activities.

• Develop and lead the execution of regulatory CMC investigational, registration, and post-approval strategies for assigned products
• Work with Process Development and Global CMC team members throughout clinical development and commercial lifecycle to align on regulatory CMC strategy to fulfill business objectives
• Obtain timely consultation with RA line management and lead interactions with regulatory consultants/ advisors as appropriate for strategic input on regulatory CMC strategy
• Develop regulatory CMC strategy and plans for Health Authority (HA) interactions as appropriate
• Plan and execute regulatory CMC submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities
• As a CMC product leader or team member, independently define and prepare high quality CMC regulatory submissions in accordance with regulations to ensure completeness and regulatory compliance for filing requirements for assigned compounds throughout development and the commercial life cycle.

Qualifications:

• Education (Minimum/desirable): Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) is highly preferred
• Languages: MUST be bilingual in English and Chinese
• 5 - 10 years of pharmaceutical regulatory CMC drug/biologic development experience, ideally spanning activities in Phases I-IV, including experience as an RA CMC product lead, or equivalent industry experience
• Experience providing CMC regulatory guidance to drug development, registration, and post-market support teams
• Innovation in regulatory CMC strategy
• Major involvement in IND/NDA/BLA submission and approval.