Team leader Regulatory Affairs

Chemilines Healthcare India Pvt Ltd

4 to 8 yrs. Ahmedabad
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Posted on 24 Apr 2017

Job Description

• Oversee the day to day management of the RA team
• Preparation of initial and variation applications for submissions to MHRA and EMA
• Monitoring pending applications to ensure rapid processing
• Responding to queries from the licensing authority
• To deal efficiently and effectively with MHRA, EMA and other regulatory agencies for various regulatory policies and issues.
• Scrutiny and internal regulatory Audits of Quality system as per guidelines and SOPs
• Co-ordination of the timely update of license statuses, including the actions required to ensure license remain active.
• Timely submission of variations including swift follow up on RFI’s
• Ensure quality of submissions to receive grants without RFI.
• Preparation/design of components (cartons, labels and patient leaflets) for internal and external printing and updating as required

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