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Regulatory Affairs Manager - Mumbai

6.00 to 8.00 Years   Mumbai City   26 Oct, 2022
Boehringer
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    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 environment, 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 REGULATORY STRATEGY AND REGISTRATION ACTIVITIES 1.) Timely execution of RA activities as per the IMETA strategy and the OPU business priorities. 2.) Compilation of the dossier as per local regulations and requirements. 3.) Maintain MA and support product shipments. 4.) Engagement with local graphic offices (if applicable) and maintenance of RA databases. 5.)Tracking and archiving the acknowledgments/dossier in hard and soft copies on common driveMANAGERIAL ACTIVITIES 1.) Involved in Budget preparation. 2.) Deputize OPU Head of RA in escalation discussion for product and non-product local topics to ROPU. 3.) Encourage innovation in our daily activities 4.) Can carry out OPU Head of RA responsibility partially or fully in an interim situation as needed.MANAGERIAL ACTIVITIES 1.) Involved in Budget preparation. 2.) Deputize OPU Head of RA in escalation discussion for product and non-product local topics to ROPU. 3.) Encourage innovation in our daily activities 4.) Can carry out OPU Head of RA responsibility partially or fully in an interim situation as needed.REGULATORY INTELLIGENCE1.) Communicate and discuss new/updated information within regulatory environment, competitive regulatory intelligence and/or new requirements in the country with the OPU and IMETA stakeholders. 2.) Support to compile the required regulatory expertise to support future BI portfolio.EXTERNAL / Internal RELATIONSHIPS AND ENGAGEMENT External Stakeholders 1.) Health Authority Interactions. 2.) Maintain successful Regulatory service Provider (RSP) relationship.,

Keyskills :
service providerssupply chainpeople managementmarket accessbusiness continuity

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