Job Description

Overview

Piper Health & Sciences is seeking an experienced and strategic Associate Director of Regulatory Affairs to lead regulatory planning and submission activities for a 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.

Responsibilities

• 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.

Qualifications

• PhD with 7+ years, Masters with 10+ years, or Bachelors 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.

Compensation

• Salary Range: $165,000 - $225,000 annually, commensurate with experience
• Comprehensive Benefits: Medical, Dental, Vision, 401k, PTO, Paid Holidays, Annual Cash Bonus, HSA, STD, LTD

This job is open for applications on 7/28/2025. Applications for this role will be accepted at least 30 days from the posting date.

Keywords: Regulatory affairs, ind, investigational new drug, ectd, clinical research, biotechnology, biopharma, tissue, organ, stem cell, cmc, regulatory, biologics, fda, gcp, good clinical practices, regulatory writing, regulatory submission, fda, parts 21, cfr, cber, gtp, good tissue practice

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