Found Description
Join Apotex as a Senior Analytical Product Life Cycle Manager, focusing on global regulatory submissions and specifications. Lead complex investigations and provide technical guidance while supporting drug development efforts.
In this senior role, you will oversee regulatory submission documents, establish drug specifications, and support new product launches within the pharmaceutical sector. Your expertise in analytical method validation, physico-chemical evaluations, and compliance will drive impact and innovation. You will also mentor team members and ensure regulatory compliance with various authorities.
Key Responsibilities:
• Prepare complex regulatory submission reports worldwide
• Evaluate physico-chemical properties and specifications of drugs
• Justify specifications through detailed documentation
• Respond to regulatory deficiency letters promptly
• Provide technical support to PD-SD units on chemistry issues
Requirements:
• PhD or MS in chemistry ...
In this senior role, you will oversee regulatory submission documents, establish drug specifications, and support new product launches within the pharmaceutical sector. Your expertise in analytical method validation, physico-chemical evaluations, and compliance will drive impact and innovation. You will also mentor team members and ensure regulatory compliance with various authorities.
Key Responsibilities:
• Prepare complex regulatory submission reports worldwide
• Evaluate physico-chemical properties and specifications of drugs
• Justify specifications through detailed documentation
• Respond to regulatory deficiency letters promptly
• Provide technical support to PD-SD units on chemistry issues
Requirements:
• PhD or MS in chemistry ...
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