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:

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

This job opens for applications on //5. Applications for this job will be accepted for at least 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, CFR 1, CFR , 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

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