Senior Director, CMC Regulatory Affairs - Permanent - Boston, MA
Ready 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:
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:
Apply today!
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at n.walker@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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