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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📌 Manager Regulatory Affairs (Delhi)
🏢 BoehringerPRD
📍 Delhi