Associate Director, Regulatory Affairs

Piper Companies; Minneapolis (MN); On-site; USD 165,000 - 225,000; Full time

Job summary

A leading biotechnology company in the Minneapolis area is seeking an experienced Associate Director of Regulatory Affairs. This role requires strong regulatory expertise, managing IND submissions, and mentoring team members in a fast-paced environment. Applicants should possess a PhD or equivalent experience in regulatory affairs, with a proven track record in regulatory submissions and project management.

Benefits

Comprehensive Benefits

401k

Paid Holidays

Annual Cash Bonus

Paid Time Off

Qualifications

• Minimum 8 years of project or people management experience.
• Proven experience in writing and submitting INDs in eCTD format.
• Strong understanding of FDA regulatory requirements.

Responsibilities

• Serve as the regulatory lead for the tissue engineering program.
• Author and manage IND submissions, including writing key sections.
• Collaborate with internal teams to ensure regulatory alignment.

Skills

Regulatory Writing

Cross-functional Collaboration

Communication Skills

Education

PhD in Regulatory Affairs or related field

Master's in Regulatory Affairs or related field

Bachelor's in Regulatory Affairs or related field

Job description

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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.

Responsibilities for the Associate Director of Regulatory Affairs:

• 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 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.
  
  

Compensation for the Associate Director of Regulatory Affairs includes:

• 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 5/30/2025. Applications for this role will be accepted at least 30 days from the posting date.

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 submissions

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Business Consulting and Services

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