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Regulatory Affairs Senior Specialist - Pharmaceuticals - Co Galway - Excellent salary and benefits
Leading generics and specialty pharmaceutical company seeks a Regulatory Affairs Senior Specialist based in Co Galway. The Regulatory Affairs Senior Specialist will be responsible for the preparation of regulatory submissions for parenteral pharmaceutical products primarily to the US market.
You should have a strong knowledge of the United States Pharmacopoeia, Title 21 of the Code of Federal Regulations and various FDA Guidance's for Industry (particularly those dealing with sterile products). Knowledge of the regulatory process pertaining to drug development, registration, review and approval. Knowledge of parenteral product submissions.
Experience in writing and submitting regulatory documentation. 2 to 4 years regulatory experience in the pharmaceutical industry.
Minimum of a Bachelor's degree (or equivalent) in a science related discipline.
Key words: FDA , Pharmaceutical , Regulatory Affairs , Drug Development , Co Galway , Ireland
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