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

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Thursday, 27 August 2020

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 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

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