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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