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.