Manger Regulatory Affairs, Labelling for Usa Market - Mumbai, India - Genpact

Genpact

Verified Company

Mumbai, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

With a startup spirit and 115,000 + curious and courageous minds, we have the expertise to go deep with the world's biggest brands—and we have fun doing it We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line.

We are harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people.

Now, we are calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower._
Welcome to the relentless pursuit of better._

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Responsibilities_

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1. Change management process of CCDS, Non-CCDS and Annual reportable labelling changes._
2. Analysis of competitor information (e.g., labels, approval packages) for regulatory policy projects and/or labelling projects_
3. Escalate, notify, and resolve any issues that may impact final labelling submission._
4. End to end responsibility of labelling for product registered in the US market._
5. Responsible for maintaining internal tracker for CCDS, Non-CCDS and Annual reportable labelling changes and submissions._
Qualifications we seek in you_
Minimum Qualifications_
B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc._

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Preferred Qualifications/ Skills_

- _Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission._
- _Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously._
- _Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables._
- _Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions._
- _Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process._
- _Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures._
- _Depending on experience level, mentor newly hired staff or lead a team of junior staff._
- _Flexibility in responding to changing priorities or dealing with unexpected events._
- _Capability to handle multiple priorities and balance work to achieve business goals._

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Job_**_Manager_

_ Primary Location__India-Mumbai_

_ Schedule__Full-time_

_ Education Level__Bachelor's / Graduation / Equivalent_

_ Job Posting__Oct 30, 2023, 2:56:04 PM_

_ Unposting Date__Ongoing_