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Regulatory Affairs Manager
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Full-time
- Regulatory Affairs Manager
- Company Akston Biosciences is inventing, developing, and manufacturing breakthrough protein therapeutics for Companion Animal Health.
- Experience 7-10 years pharmaceutical industry experience, including 3 years of experience in CMC Regulatory Affairs projects comprising biologic therapeutics.
- Should be well-versed in regulatory strategy and regulatory writing and have experience as co-author for regulatory documents, CMC, and submissions.
- Strong knowledge and proficiency in ICH, FDA and EMA guidelines, and familiarity with GMP/GCP/GLP compliance.
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