Global Labeling Manager

Novartis • East Hanover, NJ

1d • Hybrid

About The Position

The Regulatory Affairs (RA) Global Labeling Manager (GLM) is responsible for the maintenance of regulatory compliant, competitive, and up-to-date core labelling documents for assigned Novartis Innovative Medicines products. The assigned products should in general be of higher complexity products and may include developmental programs. The RA GLM provides strategic and operational regulatory labelling input and works in close collaboration with Expert Labeling Task Force (ELTF) members in maintaining core labeling documents and handling HA or CO labeling queries for assigned products.

Requirements

• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred
• Minimum 2-3 years’ experience in global labeling or other regulatory affairs functions, alternatively 5 years’ experience in related areas of the pharmaceutical industry, or Health Authorities
• 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
• Good understanding of drug safety information

Nice To Haves

• Advanced degree (MD, PhD, PharmD)

Responsibilities

• Maintain regulatory compliant, competitive and up to date global labeling documents (Core data sheet (CDS), Basic Patient leaflet (BPL), Basic Succinct Statement (BSS) for assigned products
• Organize and lead the ELTF to discuss labeling strategy and reach consensus on labeling course of action and labeling text as appropriate
• Represent Global Labeling as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products
• Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.
• Contribute to the creation of high-quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries
• Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics
• Represent GL during audits and inspections

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager