344037BR
Apr 19, 2022
India

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.

Prepares and 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 strong business partner and project team member for maintenance/compliance matters. Builds strong interface between the local functions (NTO/ESO/QA) as well as all Sandoz development/maintenance centers to ensure continuous compliance with legal, scientific (technological), ethical and administrative requirements.

Your Responsibilities:

Your responsibilities include but not are limited to:
• Provides support in order to maintain core labeling documents and create/update of product information and artwork.

• Assists departmental teams in RA activities regarding Novartis safety risk communications/portfolio stewardship activities.

• Assist facilitating harmonization and consistency between product information and global product information documents (e.g. CDS).Manages the artwork administrative office.

• Researches labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.

• Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.

• Applies company policies and procedures to resolve routine issues. Contacts are primirily with immediate supervisor and other personnel in department or group.

• Normally receives detailed instructions on all work -Typically tactical; not strategic with regards to assigned goals and objectives.

• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt .Distribution of marketing samples (where applicable)

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:
Master’s degree in a scientific discipline.
• At least 1-2 year of relevant experience in Regulatory domain with an exposure of working in global organization in generics is preferred. Fresh campus graduates with high learning agility can be considered
• Makes decisions independently with clear action
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
• Develops and supports process for labeling creation and update
• Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions.

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
SANDOZ
Product Dev SZ
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
careers default image
344037BR

Associate, Global Labeling

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