Job Description

The Position

Ensure that all regulatory updates are shared with local and global teams in timely manner. Ensure that timely and complete regulatory actions are taken regarding assigned product/therapeutic area. Ensure operational RA tasks are executed in timely manner

Tasks & Responsibilities

• Strategies comply with regulations, Liaise with Health Authority and ensure earliest submission and registration in the country.
• Follow-up regulatory approvals for the products per registration plan.
• Liaise with Health Authority and Ensure earliest submission & approvals at the right time to ensure quick implementation of proposed CMC changes as per global timelines.
• Renewal on time to ensure uninterrupted availability of products in the country.
• Amendments and updates are approved on time to ensure study is continued in the country and ensure timely notification of notifiable updates.
• Follow-up on submitted applications at HA.
• Ensure all regulatory updates are shared with local and global team in timely manner.
• Follow the RI procedure of making entry and impact assessment of each relevant update in RINTOOL to maintain RIN database.

Requirements

• Education: Bachelor’s degree in pharmacy or similar medical education.
• Pharma experience with regulatory focus in a multi-national for at least 4-6 years.
• Solid understanding of D&C Act and Rules.
• Understanding of working practices at HA.
• Experience of direct interactions with Regulatory Authorities.
• Eye for details
• Analytical skills
• Communication skills
• Negotiation skills
• Position is based in Delhi

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