Associate Director, Regulatory Affairs

Piper Companies is seeking an Associate Director, Regulatory Affairs to join a top biotechnology company in Minneapolis, MN.

Responsibilities of the Associate Director, Regulatory Affairs:

• Lead regulatory documentation and submissions for product development, ensuring compliance with industry standards and regulatory requirements.
• Develop and implement regulatory strategies to support innovative biomedical and pharmaceutical initiatives.
• Collaborate across departments to gather information and contribute to cross-functional project goals.
• Manage and mentor team members, providing leadership and guidance on regulatory processes.
• Maintain regulatory knowledge and ensure effective communication with internal and external stakeholders.

Qualifications of the Associate Director, Regulatory Affairs:

• 12+ years of professional experience in regulatory affairs
• Hands-on expertise in preparing and submitting IND applications using eCTD format through the ESG portal.
• Proven ability to shape regulatory strategies and collaborate effectively across multidisciplinary teams.

Compensation of the Associate Director, Regulatory Affairs:

• Salary: Between $165.000 - $220.000 per year based on years of experience
• Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave as required by law

This job opens for applications on 05/16/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

Regulatory Affairs, Biologics, Pharmaceuticals, IND Submission, eCTD Format, ESG Portal, FDA Regulations, Clinical Development, Organ Transplant, Bioengineered Organs, Tissue Engineering, Public Benefit Corporation, Biotech, Pharmaceutical Development, 21 CFR 1271, 21 CFR 312, Regulatory Strategy, Regulatory Submissions, Quality Assurance (QA), Quality Control (QC), Validation, Process Development, Pharmacovigilance, Project Management, People Management, Cross-functional Collaboration, Strategic Planning, Team Leadership, Mentorship, Communication Skills

#LI-AS1

#LI-ONSITE