At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, fast and always on target, we are Adalvo ? ?

We are looking for an enthusiastic Lifecycle Manager to join our dynamic Portfolio team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect prospect for you.

SUMMARY OF POSITION
Initiation, coordination and tracking of variations for the assigned medicinal products, approved through European procedures (MRP, DCP, CP) or national submissions across all regions of interest.
Coordination of variations or other activities taking into consideration the impact on product launch or replenishment orders.
Coordination and tracking of renewals and MA transfers for the assigned medicinal products, approved through European procedures (MRP, DCP, CP) or national submissions across all regions of interest.
Ensuring that all the additional processes related to national submissions (DMF, PMF,



GMP accreditation etc.) are maintained and renewed on time and that their submission/approval process does not affect the MA validity.
Ensuring that all responses to authorities’ requests are correct, complete and timely submitted, including the responses to LoDs for the allocated projects.
Collaboration with the Pharmacovigilance Department for safety variations submission.
Ensuring that complete and correct documentation is received, so that responses are sent to the authorities’ requests, within the deadline imposed by that specific authority/legislation in place.
Informing all involved departments on the status and progress of the assigned projects, so that objectives are met, any potential issue is identified and solutions are being found.
Documenting and tracking regulatory related processes within the organisation.
Compile, verify and publish submissions using electronic publishing softwa

📌 Lifecycle Manager (Mumbai)
🏢 Adalvo
📍 Mumbai