Piper Companies is currently seeking an Associate Director of Regulatory Affairs to support IND submissions and regulatory strategy for a groundbreaking biotechnology company in Eden Prairie, MN (Relocation Assistance Available)
Responsibilities for the Associate Director of Regulatory Affairs
- Serve as the regulatory lead for IND submissions and ongoing regulatory strategy
- Author core IND content, collaborating with cross-functional teams for technical input
- Submit regulatory documents
- Manage and mentor one direct report
- Lead regulatory execution for early-stage biologics and organ transplant devices
- Interface with internal leadership and external regulatory bodies to drive timelines and ensure compliance
Qualifications for the Associate Director of Regulatory Affairs
- Bachelor’s degree in life sciences or related field and 12+ years of regulatory experience, or
- Master’s degree with 10+ years
- 8+ years of project or people management experience
- Hands-on experience writing and submitting INDs in eCTD format
- Proven success navigating complex regulatory environments within biotech or pharma
Compensation for the Associate Director of Regulatory Affairs
- Salary: $165,000-$225,000 annually
- Schedule: Full-time, onsite (M–F with flexible 9–5 schedule)
- Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave, and Holidays
Application Period: This job opens for applications on 5/29//2025. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: Regulatory Affairs, IND Submission, eCTD, ESG Portal, FDA Regulations, Biologics, Regulatory Strategy, Regulatory Writing, Regulatory Submissions, Cross-functional Collaboration, People Management, Project Leadership, Biotechnology, Organ Transplant Technology, Life Sciences, GMP Compliance, Regulatory Compliance, Quality Systems, Clinical Development, Drug Development, Regulatory Lead, Regulatory Operations, Submission Planning, Risk Mitigation, FDA Interaction, Medical Writing, CMC Documentation
#LI-JM1 #LI-ONSITE
