Jul 19, 2022

Job Description

1886! We have more than 130 years of experience treating patients.
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.

Your Responsibilities:
Your responsibilities include but not are limited to:

• Preparation of regulatory maintenance submissions, variations, renewals and second wave submissions, Modules 2 to 5.
• Supports in submission preparation to ensure implementation dates of variations and file availability dates of second wave submissions are met.

• Implements proposed changes and provides regulatory input for worldwide regulatory impact. •
• Contributes to performance and KPI's of the team to deliver agreed targets and objectives and supports reporting.
• Provides DRCs/MRC sites/BD Regulatory, manufacturing business units with proper data and change evaluations to plan and implement registration activities and to meet commitments and requests of deficiency letters.

• Ensures that the escalation process to next or higher-level management is followed, as applicable. Supports in deficiency responses and rejections. •

• Supports in the receipt of proper product transfers from DRCs and BD Regulatory.

• Supports regulatory consultancy for products and NTO. Ensures proper data management

Diversity & Inclusion / EEO

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

Minimum Requirements

What You’ll bring to the role:
• Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters or Bachelors
• Good written and spoken English. Local language is an advantage
• At least 5 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
• Cross Cultural Experience.

Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 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 do here at Sandoz!

Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Product Dev SZ
Hyderabad, AP
Research & Development
Full Time
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Specialist, MRC

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