May 10, 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:

• Leads, directs and motivates the team, ensures staff training and development to maximize regulatory and technical competence for global labelling submission scenarios to ensure patient safety.
• Defines labeling and submission strategy for EU and interacts with HA as required. Defines end to end labeling strategy for Sandoz Small Molecules and implements as defined by internal timelines.
• Ensures timely and adequate updates of the core safety information (for Generics ) Ensures detection of safety label updates from Health Authority websites and/or Health Authority publications, as well as changes to the label of Reference products, and evaluation of these, as per applicable procedures.
• Monitors performance and KPIs of the Labelling Team, takes corrective action where appropriate to deliver agreed targets and objectives.Acts as a competent and strong business partner to ensure alignment and effective coordination of maintenance activities across cross-functional teams (such as Medical, Pharmacovigilance, QA, etc) and country organizations.
• Supports management decisions across regulatory, safety and labelling scenarios.Ensures efficient working methods in accordance with the Guide to Good Regulatory Practice and internal guidelines, as applicable.Ensures proper coordination and implementation of global projects and initiatives.
• Ensures that the escalation process to next or higher level management is followed as applicable.Ensures that requirement overviews and new trends on safety label variations are available, constantly updated and trained as appropriate.
• Ensure in-time hand-over of labeling variation package or response documents to submission teams.Coordinate and drive independently labelling projects or specific safety tasks as assigned.
• Represent Global Labelling team in inspections/audits and other Sandoz/Novartis boards as requiredLead SOP revisions, Deviations/Escalations/CAPA as assigned.

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:
• 5-8 years’ experience in a leadership role12+ experience in regulatory affairs and/or labeling
• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player
• Ability to provide strategic guidance to stakeholders
• Strong interpersonal, project management, communication, negotiation and problem solving skills.
• Ability to lead cross-functional teams in a matrix environment Organizational awareness (interrelationship of departments, business priorities)
• Sound understanding of medical and scientific terminologies
• Sound understanding of drug safety information ,High level of organizational awareness and strong quality and customer focus.

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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Group Head, Labeling

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