Amneal Pharmaceuticals - Urgent Openings in Regulatory Affairs (OSD / Injectable) - Apply Now

 

Opening in Regulatory Affairs (OSD / Injectable)-For US Market-Amneal

Dear Candidate,

We have urgent openings in the Regulatory Affairs department. Please see below details further and request to share your updated CV at kavitriy@amnealindia.com

Regulatory Affairs-OSD/Topical

Market Exposure (US Market Exposure is Must)

Designation-Executive/Senior Executive

Qualification: B. Pharm/M. Pharm

Experience: 3-7 yrs

Job Description:

• US ANDA complete life cycle handling experience, specifically the supplements and annual Reports submissions
• Basic Regulatory knowledge of Dosage forms incl. Solid oral (Tablet, Capsules), Liquid oral (Solution, Suspension)
• Basic Knowledge of, FDA guidance for Generic drugs, ICH Quality guidance especially Stability and Impurity requirements, Refuse to receive and Stability Question & Answer guidance, SUPAC guidance, supplement and Annual report related FDA guidance, Post approval CMC experience is highly desirable.
• Experience of handling change control assessment (via Track wise, QUMAS if explored), and accordingly prepare and submit relevant CBE0, CBE30, PAS, Annual Reports
• Review batch records, annual reports, and CMC documents
• Coordinate work with CMO, Regulatory CFT teams for regulatory submissions
• Clear verbal and written communication skills
• Good regulatory review skills of all CTD section related data

Regulatory Affairs-Sterile/Injectable/Ophthalmic

Market Exposure (US Market Exposure is Must)

Designation-Executive/Senior Executive

Qualification: B. Pharm/M. Pharm

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