Jun 07, 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.

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:

• Performs tasks assigned as per applicable procedures (e.g., GOPs, SOPs, WIs). CDS and core English SmPC/PIL/Label (in line with CDS and all relevant HA signals) preparation and maintenance.

• Signal Detection & Evaluation: perform external signal detection by monitoring HA websites and/or the reference product label, and enter identified signals into the CDS & SD database. Evaluate signals from any source for their impact on patient safety, and decide on actions to be taken to mitigate related risks.

• Organization of translations if needed and readability testing of package leaflets. Maintain core SmPC/PIL/Label based on CMC or administrative changes. Define submission strategy for EU and interact with HAs as needed.

• Define submission strategy for EU and interact with HAs as needed. Ensure in-time hand-over of variation package or response documents to submission teams. Ensure update of internal databases/RIMS.

• Collaborate with Regulatory Associates and Specialists for assigned tasks to enable timely submissions. Prepare and maintain SOPs/WIs/guidelines as assigned. Maintain documentation and perform administrative actions as required.

• Maintain documentation and perform administrative actions as required. Support to country organization as appropriate. Support compliance/performance reporting and oversight.

• Support labelling projects, audit and inspections, and other specific tasks as assigned. Represent global labelling team in internal (safety) boards and present specific topics when needed.

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:
• 5-6 years of experience in global labelling or other regulatory affairs functions, alternatively 5 years’ experience in related areas of the pharmaceutical industry, or Health Authorities.
• Simplifies and standardizes routine activities to the extent possible, while not compromising on scientific product knowledge and evaluations
• Ability to lead cross-functional teams in a matrix environment
• Organizational awareness (interrelationship of departments, business priorities)
• Sound understanding of medical and scientific terminologies
• Good understanding of drug safety information
• Strong interpersonal, project management, communication, compliance/quality mindset, negotiation and problem-solving skills. Good understanding of drug/patient safety information

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
Product Dev SZ
Hyderabad, AP
Research & Development
Full Time
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Global Labelling Manager

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