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Regulatory Affairs Specialist
External job listingat Splintpharma
About the role Pharmaceutical / Biotech Requirements 3–5 Years FDA regulatory submissions & compliance IND / NDA / ANDA experience 21 CFR, ICH & GCP guidelines Regulatory documentation &...
External source - not verified3 weeks agoOpen until: Jan 12, 2027
Salary
Not provided
Location
New York, United States
Employment type
Full time
Workplace
Not provided
Regulatory Affairs Specialist
New York, United States
Job description
About the role
Pharmaceutical / Biotech
Requirements
- 3–5 Years
- FDA regulatory submissions & compliance
- IND / NDA / ANDA experience
- 21 CFR, ICH & GCP guidelines
- Regulatory documentation & submission management
- eCTD / CTD publishing
- Labeling, lifecycle management & change control
- Strong documentation and cross-functional collaboration
How to apply
- Send your updated resume and contact details via DM.
Location
- New York, NY
- Boston, MA