Job Description

Role & responsibilities: Responsible for all Deficiency management of US Market Skill to compile & review ANDAs & their Deficiency responses. Experience of working on IND / 505(b)(2) / Innovations projects for US market. Good analytical and formulation understandings of various dosage forms. Sound knowledge of Regulatory Science and Regulatory Intelligence. Thorough understanding of US ANDAs / GDUFA / ICH guidance. To provide support to cross functional teams to ensure quality and timely submission of the NDA/ANDA/Def. responses. Preferred candidate profile : Must have experience of IRA US market more than 2 years. Critical thinking ability, problem solving skill, regulatory writing skill, and communication skills are very much desired Ready to work at Ahmedabad location. Work from Office only.