Manager Regulatory Affairs Human Pharma (Mumbai)

Manager Regulatory Affairs Human Pharma (Mumbai)

13 Aug
|
Boehringer Ingelheim
|
Mumbai

13 Aug

Boehringer Ingelheim

Mumbai

The Position To Manage execute the local RA activities according to ROPU RA strategies and local business priorities within the defined timelines Maintain product registrations and RA databases ensuring business continuity in compliance with internal and external regulations and requirements Provide regular regulatory intelligence on changes in regulatory workplace competitor activity and opportunities to enable the business to realize risk or opportunities arising in the RA environment Collaborate cross-functionally and make sure that all relevant stakeholders are timely and pro-actively updated on relevant RA topics Have a strong interaction and partnership with the assigned authorities across in the OPU cluster Maintain efficient relationships with related Regulatory service Providers local agents and vendors Carry out agreed actions for the assigned local projects Can deputize the OPU RA Head in external internal stakeholders engagement as required Support the OPU RA head in the continuous development of the team Tasks Responsibilities Timely execution of RA activities as per the META strategy and the OPU business priorities Compilation of the dossier as per local regulations and requirements Maintain MA and support product shipments Engagement with local graphic offices if applicable and maintenance of RA databases Tracking and archiving the acknowledgments dossier in hard and soft copies on common drive Involved in Budget preparation Deputize OPU Head of RA in escalation discussion for product and non-product local topics to ROPU Encourage innovation in our daily activities Communicate and discuss new updated information within regulatory workplace competitive regulatory intelligence and or new requirements in the country with the OPU and META stakeholders Support to compile the required regulatory expertise to support future BI portfolio Adherence to BI SOPs ROPU processes and local regulations Contribute to CAPA process as appropriate Perform day-to-day

📌 Manager Regulatory Affairs Human Pharma (Mumbai)
🏢 Boehringer Ingelheim
📍 Mumbai

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