What are the responsibilities and job description for the Senior Research Associate, RA position at AVEVA DRUG DELIVERY SYSTEMS INC?
Job Details
Description
1. Good understanding on the Product development pathway on the Complex Injectable and Ophthalmic formulation (Suspension, Emulsion, Microsphere, Liposomes, and Peptide molecules)
2. Review and compilation of Product development report, Master documents related to CMC data considering the current expectation of the regulatory requirements.
3. Complete understanding on the Quality by design concept of the Product development Report and bridging analysis for the Global development.
4. Preparation of amendments, supplements, drafting the CMC responses, briefing book, controlled correspondences to the regulatory agencies during development, registration and the product life cycle management.
5. Excellent verbal and document drafting skills are mandatary.
Qualifications
M. Pharmacy (Pharmaceutics) and Expertise in Regulatory affairs workflows.
Salary : $6 - $9
