Regulatory Affairs Associate I
Baxter Parkway Riverwoods, IL 60015 US
Job Description
The role will aid GRLs (Global Regulatory Lead) with obtaining and creating registration documentation. Including but not limited to creating cBoMs, downloading information from TCU, creating declaration letters for GRL and Quality Representatives to sign, coordinate FSC (Free Sale Certificate), CFG (Certificate to Foreign Government), and Export Certificate requests. Also, the role could also aid in creating draft global regulatory strategies and/or US regulatory decisions.
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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.