Specialist

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

• 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

Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do 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