Job Description

About the role

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 Sandoz\xe2\x80\xa6 are you ready to make a difference?
Job Purpose:
Implements regulatory maintenance activities and second wave submissions to achieve targets and business objectives in accordance with the submission plan to avoid stock-outs and delayed launches. Ensures that preparation of variations follow established processes and timelines. Acts as interface between the local functions (STO/ESO/QA) as well as all Sandoz development/maintenance centers to ensure continuous compliance with legal, scientific (technological), ethical and administrative requirements.

Your 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\xc2\xb4s 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 higher-level management is followed, as applicable.
• Supports in case of rejections investigation.
• Ensures the receipt of proper product transfers from DRCs, MRCs and BD Regulatory. Provides regulatory consultancy as and when requested by STO/ESO.
• Ensures proper data management and completion of all assigned trainings within specified timelines.

Role Requirements

Education Requirements :
Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters or Bachelors

Languages :
Good written and spoken English. Local language is an advantage
Experience/Professional :
Requirements
At least 5 - 7 years of relevant experience in the domain of regulatory with an exposure of working in global organization in generics is preferred. Exposure towards project management is a plus. Well-structured, result-oriented, highly self-committed, resilient, flexible, team player. High operational excellence orientation

Functional Area

Research & Development

Division

SANDOZ

Business Unit

Sandoz Global Development

Employment Type

Regular

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.

Shift Work

No

Early Talent

No

Novartis