Executive Regulatory Affairs

1 month ago

mumbai, India Piramal Group Full time

Business: Piramal Critical Care 
Department: Regulatory Affairs
Location: Kurla, Mumbai
Travel: Low

Job Overview

To manage Regulatory Filings for Europe with minimum supervision. 

Key Stakeholders: Internal Country manager, Plant, QA , Artwork department, Supply Chain, PV
Key Stakeholders: External  Health Authorities, Distributors
Reporting Structure Reports into the Manager- Regulatory Affairs 
Experience Minimum to years relevant experience in handling Europe market. Over all total experience in Regulatory of - years
Competencies: Good communication skills both spoken and written English  Should be well versed with using excel sheets, Powerpoint etc.  Ready to take challenges in work Ready to move to different locations for work as and when required Will need to do coordination intra and inter department and across sites globally  Should be good at review of documents and should have good technical knowledge  Should be able to do multitasking 

Key Roles & Responsibilities:

Under the guidance of the Team Leader, this person should be able:

To submit the product registration dossier of assigned products to targeted countries in Europe as per eCTD requirements. To file all the required variations and Renewals of assigned products in line with guidelines and checklists as per the plan. To respond to queries received from regulatory agencies, business unit or other stake holders by ensuring complete and accurate information is provided within predefined timelines.  To review product labeling updates in EU. To maintenance of various data bases in timely manner. To update himself/herself with the relevant current EMEA, National and ICH guidance’s and requirements. To provide required support to Pharmacovigilance team as and when required  To ensure support in execution of any projects assigned as per business need.

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