Regulatory Affairs Associate
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Accentuate Staffing is assisting a biotech client who is looking to double their headcount within the next 6 months. We have multiple positions in Regulatory Affairs available for those that want to be part of an exciting company and be part of helping to set the direction. These are direct hire opportunities!
Responsibilities:
- Will prepare and review regulatory documents related to IND submissions
- Contributes/authors/reviews clinical, CMC and nonclinical components of eCTD modules for INDs and briefing documents
- Prepares and manages submissions (CMC, Clinical, nonclinical; amendments, supplements and briefing materials) that are technically complex and require extensive interaction with departments outside of regulatory affairs
- Responsible for tracking annual budgets and forecasting for programs. Ensures all expenditures are managed in accordance with agreed budgets and forecasts and notifies regulatory staff when issues arise
- Maintain basic knowledge of applicable regulations (GMP, GLP and GCP) and consult with project team members regarding regulatory matters.
Requirements:
- BS/BA degree, PhD preferred (life sciences preferred)
- Minimum of 1 to 3 years of applicable experience (biotech/pharma/research firm) with at least 1 year in a regulated role preferred
- Ability to multitask among multiple projects and teams and work independently in a fast-paced, highly interactive environment
