Job Title

Position Details:Designation: ManagerBusiness Unit: Research & DevelopmentLocation: Navi MumbaiOverall Job Responsibilities:- Highly experienced in submission of initial dossier and deficiency responses to US, EU, UK, Canada and Australia Agency for injectable and ophthalmic products. - Hands-on experience in co-ordination and communication with cross-functional teams and in-licensing partners to ensure timely technical and administrative support. - Review and approve technical/master documents to ensure compliance with submission requirements before execution of batches and developmental studies. - Preparation and submission of controlled correspondence/scientific advice to agency. - Enlist, review and circulate the gaps in initial and deficiency response submissions to stakeholders. Ensure that identified gaps are closed satisfactorily. - Training to sub-ordinates on technical requirements and guidance updates. - Timely and accurate evaluation of change controls from R&D and plant along with proper review of supportive and updated documents. - To keep abreast of latest regulations, interpreting and understanding of guidance's and disseminating the information to all concerned. - Technically support activities of under development in-house and in-licensing injectable and ophthalmic products. - Timely and accurate review of technical and administrative documents.Educational Qualification: Master of Pharmacy (M.Pharma)Experience: 10+ years of relevant experience in Regulatory Affairs.Interested candidates with relevant experience can apply.