Drc Associate - Hyderabad District, Telangana, India - Novartis

Novartis
Novartis
Verified Company
Hyderabad District, Telangana, India

2 weeks ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter
Description
2023 will potentially see Sandoz become a standalone organization Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, passionate organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally
Together we will shape the future of Sandozare you ready to make a difference?

Job Purpose:


Provides effective operational and regulatory support to Novartis as well as to regional/global organizations for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives and artwork-related activities.


Your Key Responsibilities:
Coordinates and prepares high quality submissions of regulatory dossiers for assigned products.


Ensure license renewal Submission and approval on time; Ensure CMC/BPI/PSUR/RMP in line with NMPA regulation and Novartis internal policies; Ensure registration master file update.

Assist to coordinate f2f meeting with CFDA/CDE for new project discussion. Communicate the questions referred by HAs timely and smoothly.
Timely update and communicate the registration status to the line manager. Timely order and tracking the registration sample, dossier, certificates.
Provide regulatory support for other functions (marketing, medical, sales, MA&C, TechOps. Start to establish good communication and relationship with key stake holders.
Get familiar and with company and department SOP and working procedures.

Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.

Distribution of marketing samples (where applicable)


Commitment to Diversity & Inclusion:


  • Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve._

Minimum requirements

What you'll bring to the role:

  • Someone who has hands-on experience in pre-approval stage.
Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.

That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.

And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges.

Because the greatest risk in life, is the risk of never trying
Imagine what you could achieve here at Sandoz

Commitment to Diversity & Inclusion:


Sandoz is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.


Division

SANDOZ

Business Unit
Small Molecules STO


Country
India


Work Location
Hyderabad, AP


Company/Legal Entity
Sdz Pvt Ind


Functional Area
Research & Development


Job Type
Full Time


Employment Type
Regular


Shift Work
No


Early Talent
No
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