Regulatory Affairs Manager

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.