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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