Associate Director of Regulatory Affairs

New Today

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 + years of regulatory experience, or Master’s degree with + 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: $,-$, annually Schedule: Full-time, onsite (M–F with flexible 9–5 schedule) Benefits: Medical, Dental, Vision, K, PTO, Sick Leave, and Holidays Application Period: This job opens for applications on 5///5. Applications for this job will be accepted for at least 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
Apply
Location:
Eden Prairie
Job Type:
FullTime

We found some similar jobs based on your search