Piper Companies is looking for an Assistant Director of Regulatory Affairs to join a biotechnology company focusing on products to address life threatening conditions. This is a full-time position and onsite in Eden Prairie, MN (relocation assistance available).
Essential Duties of the Assistant Director of Regulatory Affairs:
- Main point person responsible for writing INDs.
- 50-60% of time will be writing related. Writing sections of IND with support of cross functional teams.
- Opportunity to gain people management experience if you do not have that already. This person will be managing 1 person.
Qualifications of the Assistant Director of Regulatory Affairs:
- Bachelors Degree and 12 years, Masters Degree and 10 years, or PhD and 5 years of experience in biologic or pharma industries.
- Must have IND experience being the point person and submitting it in ECTD format through ESG portal. Regulatory Affairs experience in a pharma or biotech company.
Compensation for the Assistant Director of Regulatory Affairs:
- $165,000 - $225,000 (based on experience)
- 20% annual cash bonus
- 20% annual stock option
- Comprehensive benefit package; Cigna Medical, Cigna Dental, Vision, 401k w/ ADP, PTO, paid holidays, Sick Leave as required by law, paid holidays
This job opens for applications on 5/20/2025. Applications for this job will be accepted for at least 30 days from the posting date.
#LI-LS3 #LI-ONSITE
Keywords: 401k, 401k match, pto, paid time off, holiday, medical, dental, health, culture, reg affairs, regulatory affair, regulatory affairs, biotech, biotechnology, biologic, biology, chemistry, investigation of new drugs, pharma, pharmaceutical, new drugs, ectd, ectd format, esg, fda, electronic submission gateway, electronic submissions gateway, nda, bla, anda, dmf, dmfs, blas, andas, ndas, inds, regulatory document, regulatory submissions, electronic common technical document, kidney, heart, liver, life science, life sciences, doctorate, industry, fda regulation, regulations, food drug administration, lung, lungs, kidneys, hearts, livers,
