Position: Pre approval submission

Designation: Asst. Mgr / Sr. Executive

Experience: 4-8 Years

Dosage Form: Injectable (Aseptic processing, Terminal sterilization, Lyophilized products) Ophthalmic product, Complex Products (Peptides, Microsphere), Combination products

Job Description:

· US ANDA filing experience for sterile / injectable products including query handling  

· Regulatory knowledge of Dosage forms including-

· Injectable (Aseptic processing, Terminal sterilization, Lyophilized products)

· Ophthalmic product

· Complex Products (Peptides, Microsphere)

· Combination products

· Knowledge of FDA guidance for Generic drugs (eg. RTR guidance, ANDA content & format)

· Regulatory strategy preparation

· Basic knowledge of regulatory strategy for product (Controlled Correspondence, GDUFA etc.)

· DMF review

Interested candidate may forward their updated cv atkavitriy@amnealindia.com

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