Director of Regulatory CMC

Director, Regulatory, CMC

Location: Hybrid – Princeton, NJ Area

Therapeutic Area – Oncology

Scientific Search has partnered with an exciting biotech company that is currently in the clinic and looking to build out a Director, Regulatory, CMC. This role will lead the development and execution of CMC regulatory strategy for the Company’s assets. This role will report to the Executive Director/Head of Regulatory CMC.

Responsibilities

• Serve as the primary interface between CMC subject matter experts (SMEs) and Regulatory Affairs. Coordinate and lead all CMC regulatory projects, including budget, timelines, and CMC submission planning, ensuring all deliverables are met on time and within scope.
• Develop and align global regulatory CMC strategies with overall product development plans and company goals. Assess proposed manufacturing process changes and provide strategic regulatory guidance for global implementation.
• Act as the Regulatory CMC contact with regulatory authorities. Plan, prepare, and lead strategic CMC-related health authority meetings.
• Independently plan, execute, and manage CMC submissions and responses to CMC-related Agency queries for assigned compounds in various phases of clinical development, global marketing applications, and post-approval activities.
• Identify and mitigate potential regulatory risks related to CMC.
• Ensure CMC activities comply with relevant regulatory guidelines (FDA, EMA, ICH, etc.). Provide regulatory support for quality systems such as change control and inspection management. Support interactions with regulatory agencies during inspections.
• Work with CMC, Quality, other departments, CMOs, the EU QP, and external vendors to integrate CMC regulatory strategies into overall product development plans. Provide CMC-related regulatory guidance to other functional areas, including Manufacturing and Quality, throughout the product lifecycle.
• Ensure project team colleagues, line management, and key stakeholders are informed of developments that may impact regulatory success.
  
  

Requirements

• Bachelor’s degree in scientific discipline required (chemistry preferred); Master’s or Ph.D. preferred.
• Minimum of 8 years of industry experience in regulatory affairs CMC. Experience with small molecule solid dosage forms is required and oncology products is highly desirable. In-depth knowledge of global CMC regulatory requirements and guidelines.
• Proven track record of successful CMC submissions for INDs, NDAs/BLAs, and other regulatory filings.
• Excellent written and verbal communication skills.
  
  

How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to tom@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume.