Piper Health & Sciences is seeking an experienced and strategic Associate Director of Regulatory Affairs to lead regulatory planning and submission activities for biotechnology company in the Minneapolis, MN area. This role will serve as the primary regulatory strategist and writer, responsible for authoring and managing IND submissions and is REMOTE with 20% travel domestic/international required.

QUALIFICATIONS FOR THE ASSOCIATE DIRECTOR OF REGULATORY AFFAIRS:

• PhD with 7+ years, Master’s with 10+ years, or Bachelor’s with 12+ years of regulatory experience in biologics or pharmaceuticals.
• Minimum 8 years of project or people management experience.
• Proven experience in writing and submitting INDs in eCTD format via the ESG portal.
• Strong understanding of FDA regulatory requirements and biologics development.
• Excellent written and verbal communication skills; ability to synthesize complex data into clear regulatory narratives.
• Demonstrated success in cross-functional collaboration and regulatory strategy execution.

• Serve as the regulatory lead for the tissue engineering program, advising on regulatory pathways and submission strategies.
• Author and manage IND submissions, including writing key sections and coordinating cross-functional input.
• Ensure timely and compliant submission of regulatory documents in eCTD format via the ESG portal.
• Maintain regulatory timelines and documentation to support clinical development milestones.
• Manage and mentor one direct report, fostering professional growth and team collaboration.
• Collaborate with internal teams (clinical, quality, CMC, nonclinical) to ensure regulatory alignment across programs.
• Stay current with evolving FDA regulations and guidance relevant to biologics and regenerative medicine.