Director, Regulatory CMC

Company: Apex Systems
Location: Boston
Posted on: June 2, 2025

Job Description:

Job Overview: Reporting to the Head of Regulatory Affairs CMC, the Director will lead CMC regulatory strategies, align global requirements with development plans, and manage submissions and interactions with Health Authorities, driving team and corporate objectives.Primary Job Responsibilities:

• Develop CMC regulatory strategies, pinpointing critical issues and acceleration opportunities.
• Serve as the regulatory point of contact in internal and cross-functional CMC meetings.
• Guide project teams on global CMC regulatory strategies and compliance requirements.
• Initiate and lead proactive discussions with global health authorities.
• Organize and engage in CMC regulatory interactions with agencies like FDA and EMA.
• Assist in GMP inspections and manage comprehensive regulatory submissions.
• Collaborate with external contractors to maintain and update regulatory plans.
• Oversee CMC regulatory project reviews, budget management, and routine updates.
• Keep informed on new CMC regulatory policies and manage resolution of regulatory issues.Primary Job Requirements:
  • Bachelors in science with 10+ years in CMC Regulatory Affairs with escalating responsibility within the biopharma sector.
  • Experience in securing approvals for market applications is mandatory.
  • Must possess global post-approval product life-cycle management experience.
  • Proven track record in strategic drug development and commercial support.
  • Demonstrated success in global regulatory affairs, including drug registrations in US, EU, and beyond.
  • Strong leadership with adept communication skills for influential regulatory strategy guidance.
  • Independent work ethic, commendable teamwork, and excellent oral/written communication proficiency.
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Keywords: Apex Systems, Boston , Director, Regulatory CMC, Executive , Boston, Massachusetts