Regulatory Affairs Manager

Manager Regulatory Affairs - Delhi

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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Experience Level

Mid Level