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Director Regulatory Affairs
3 months ago
Director of Regulatory Affairs
Location:
Rockville, MD or Remote
Summary
Join my client, a pioneering biotech firm revolutionizing hemostasis management. As the Director of Regulatory Affairs, you'll lead the charge in ensuring regulatory compliance and driving strategic initiatives for groundbreaking platelet-based products that save lives.
Why You Should Apply
Lead the regulatory strategy for life-saving biotech innovations.
Work remotely with a dynamic and dedicated team.
Competitive salary
Influence global regulatory landscapes.
100% paid Medical, Dental and Vision
Stock Options and Tuition Assistance + much more…..
What You’ll Be Doing:
Craft and execute regulatory strategies for blood products aligned with business goals and global requirements.
Ensure compliance with FDA, EMA, and other regulatory bodies.
Oversee preparation and submission of regulatory documents (IND, BLA, international submissions).
Engage with regulatory agencies representing the company.
Collaborate with Clinical Development to ensure compliance in clinical trials.
Stay current on regulatory developments.
About You:
Master’s degree required, Ideally in a relevant field such as Regulatory Affairs, pharmacy, law, or public health.
Advanced regulatory affairs certifications.
10+ years experience with a minimum of 5 in regulatory affairs for blood products.
Proven leadership and team management skills.
Experience in the FDA’s Office of Blood Products is a plus.
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 ava@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume. Please include Job #18787.
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