Position Details:
Designation: Manager
Business Unit: Research & Development
Location: Navi Mumbai
Overall 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.
