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
No comments:
Post a Comment