Associate - Reg. Affairs - Mumbai, India - Genpact

Genpact

Verified Company

Mumbai, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

With a startup spirit and 90,000+ 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 in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line.

We're 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're 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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The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & processdriven environment._
Responsibilities_

- _Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the LATAM and Canadian Submissions._
- _Performing final technical quality review._
- _Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;_
- _Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders;_
- _Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata._

Qualifications we seek in you_
Minimum qualifications_

- _B. Pham/M.Pharm/Science Graduate_
- _In depth working knowledge of ECTD types of submission, industry standard publishing systems._
- _Effective time management and organizational skills_
- _Effectively communication_
- _Flexibility to adapt to a changing environment_
- _Good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc._

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Preferred Qualifications_

- _Experience in Pharmacy Regulatory Affairs_

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_Job__Associate_

_ Primary Location__India-Mumbai_

_ Schedule__Full-time_

_ Education Level__Bachelor's / Graduation / Equivalent_

_ Job Posting__Apr 11, 2023, 3:53:34 AM_

_ Unposting Date__Ongoing_