Associate Mrc - Hyderabad, Telangana, India - Novartis

Novartis

Verified Company

Hyderabad, Telangana, India

2 weeks ago

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, purpose-driven 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?

Position Purpose:

Implements regulatory maintenance activities to achieve targets and business objectives in accordance with the submission plan to avoid stock-outs and delayed launches.

Ensures that preparation of variations and second wave submissions follow established processes and timelines.

Key Responsibilities:

Preparation of regulatory life cycle maintenance submissions variations, renewals and second wave submissions, Modules 2 to 5 as per defined timelines.
Evaluates proposed changes and provides on time regulatory input for worldwide regulatory impact.
Contributes to performance and KPI ́s of the team to deliver agreed targets and objectives and supports reporting.
On time response to HA commitments and deficiency letters.
Ensures that the escalation process to next or higherlevel management is followed, as applicable.
Ensures the receipt of proper product transfers from DRCs, MRCs and BD Regulatory.
Ensures proper data management and completion of all assigned trainings within specified timelines.
Any other responsibility assigned after training (as applicable).

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements

At least 24 years of proven experience in regulatory with an exposure of working in global organization in generics is preferred. Campus graduates with agility can be considered.
Exposure towards project management is a plus.
Wellstructured, selfcommitted, resilient, flexible, team player.
High operational excellence orientation

Division

SANDOZ

Business Unit
Sandoz Global Development

Country
India

Work Location
Hyderabad, AP

Company/Legal Entity
Nov Hltcr Shared Services Ind

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Early Talent
No