Senior Director, CMC Regulatory Affairs

Company: Proclinical Group
Location: Boston
Posted on: March 29, 2025

Job Description:

Senior Director, CMC Regulatory Affairs - Permanent - Boston, MAReady to shape the future of biopharma innovation?Proclinical is seeking a dynamic, visionary leader who thrives at the intersection of science, strategy, and global regulatory frameworks. As our Senior Director of CMC Regulatory Affairs, you'll play a pivotal role in driving the regulatory journey of cutting-edge product candidates-from research breakthroughs all the way through to market approval.Your Impact:You'll champion the global regulatory strategy for Chemistry, Manufacturing, and Controls (CMC), navigating complex regulatory landscapes (EU, US) to ensure our therapies transition smoothly from development into patients' lives. Your work will blend strategic oversight with tactical excellence-leading submission processes, coordinating across internal teams and external partners, and mentoring an exceptional regulatory affairs team.The Role in Brief:

• Strategize & Submit: Craft and execute robust global CMC regulatory strategies; lead the development, review, and submission of regulatory dossiers (IND/IMPD/MAA/BLA).
• Innovate & Collaborate: Drive cross-functional collaboration, integrating regulatory insights seamlessly into product development and clinical programs.
• Mentor & Lead: Guide a talented regulatory affairs team, nurturing their growth and empowering them to achieve excellence.
• Engage & Influence: Manage relationships with global regulatory agencies, external partners, and contractors, ensuring timely and compliant submissions.Who You Are:You're an accomplished regulatory affairs expert with a strategic mindset and deep experience in biologics or bio-pharmaceuticals. A natural leader, you're adept at managing complex projects and inspiring teams to excel. You communicate clearly, resolve challenges proactively, and approach regulatory hurdles with innovative solutions.Key Qualifications:
  • MSc or PhD in Life Sciences, Bio-engineering, or related discipline.
  • 12+ years in (bio)pharmaceutical Regulatory Affairs (CMC focus).
  • Proven experience leading CMC regulatory submissions (IND/IMPD/MAA/BLA).
  • Deep expertise in GMP, GLP, GCP, GDP, GRP, and global regulatory environments (EU/US).Apply today!
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Keywords: Proclinical Group, Boston , Senior Director, CMC Regulatory Affairs, Executive , Boston, Massachusetts