Global Labeling Manager - Regulatory Affairs

Job description

Job Description

The Regulatory Affairs (RA) Global Labeling Manager (GLM) is responsible for the maintenance of regulatory
compliant, competitive, and up-to-date core labeling documents for assigned marketed products
throughout the product lifecycle in accordance with Novartis policies and procedures.
The RA GLM provides strategic and operational regulatory labeling input and works in close
collaboration with Expert Labeling Task Force (ELTF) members, DRA sub-teams, and CPOs to
ensure that core labeling documents are aligned with the company’s position on the product’s
profile and are in accordance with Novartis labeling processes and standards.
Regulatory Labeling Strategy:
Represent RA GL as a core member of Safety Management Teams (SMTs) and RA subteams
for their assigned marketed products.
Review and assess competitor labeling for marketed products within the same
pharmacological class to support key projects and periodic core labeling updates.
Review and assess local country labels to identify deviations from the core labeling and
propose topics for further cross-functional assessment during the periodic core labeling
review process
Contribute to RA activities regarding Novartis safety risk communications/portfolio
stewardship activities having labeling impact for their assigned projects/products.
Contribute to overall Global Labeling and liability risk management strategy for Novartis
Pharma including review of inter-divisional or cross-company pharmacovigilance agreements.
Regulatory Labeling Activities:
• Global Product Information: Maintain regulatory compliant, competitive and up to date core
labeling documents (Core Data Sheet (CDS), Basic Patient Leaflet (BPL), Basic Succinct
Statement (BSS), and International Package Leaflets (IPL)) for assigned marketed products.
Ensure adequate reflection of key regional/CPO input (e.g. EU, US) when revising the CDS.
• CDS Supporting Documents: Contribute to the creation of high quality documents supporting
changes to the CDS with internal and/or external experts including the preparation of
responses to labeling-related Health Authority queries.
• Global Labeling Committee (GLC): Present and defend proposed changes to global core
labeling documents, including labeling documents in key markets, to the GLC for review and
approval. Ensure that key country label proposals which deviate from a proposed CDS or
CDS amendment/update (e.g., US PI, EU SmPC) are brought to the attention of the GLC,
together with rationale.
Page 2 of 3
• Portfolio Stewardship Board (PSB): Support the Portfolio Stewardship process as a GL
representative by contributing to input impacting all labeling related topics and follow-up
activities for assigned marketed products.
Expert Labeling Task Forces (ELTF): Organize and lead cross functional ELTF meetings
(including experts from RA, Clinical, DS&E, DMPK, PCS, Reg CMC, etc) to reach consensus
on global labeling matters, assess impact of regional/local labeling changes on the CDS, and
lead subject matter experts in the preparation of high-quality supporting documents for CDS
updates and amendments for assigned products. Lead ELTF meetings to review HArequested
labeling deviations and assist GPRD/GPRMs/DRA CPOs with the preparation of an
appropriate response document. Present HA-requested deviations with an impact on the CDS
to the GLC/PSB.
• Interactions with DRA worldwide: Interact with DRA Country Pharma Organizations (CPOs)
and regional Global Program Regulatory (GPRM) /GMRMs to ensure timely implementation of global safety labeling
changes in local product information, international consistency with the company’s safety
position defined in the CDS, and compliance with local labeling regulations. Guide/ support
RA CPOs and GPRM/GMRMs for all labeling related HA negotiations. Assess country-specific
deviations from the CDS for assigned marketed products.
• Periodic Safety Update Report (PSUR): Provide DRA input to PSURs for assigned products.
• Other: Provide support to GL-TALs or Sr. Global Regulatory Managers as required.
Excellence and Compliance:
Contribute to global labeling management and continuous improvement initiatives. Review and
comment on emerging internal and external guidelines and regulations on regulatory, safety,
and legal topics.
Ensure compliance with global regulatory requirements and adherence toRegulatory Labeling Strategy:
Represent RA GL as a core member of Safety Management Teams (SMTs) and RA subteams
for their assigned marketed products.
Review and assess competitor labeling for marketed products within the same
pharmacological class to support key projects and periodic core labeling updates.
Review and assess local country labels to identify deviations from the core labeling and
propose topics for further cross-functional assessment during the periodic core labeling
review process
Contribute to RA activities regarding Novartis safety risk communications/portfolio
stewardship activities having labeling impact for their assigned projects/products.
Contribute to overall Global Labeling and liability risk management strategy for Novartis
Pharma including review of inter-divisional or cross-company pharmacovigilance agreements.
Regulatory Labeling Activities:
• Global Product Information: Maintain regulatory compliant, competitive and up to date core
labeling documents (Core Data Sheet (CDS), Basic Patient Leaflet (BPL), Basic Succinct
Statement (BSS), and International Package Leaflets (IPL)) for assigned marketed products.
Ensure adequate reflection of key regional/CPO input (e.g. EU, US) when revising the CDS.
• CDS Supporting Documents: Contribute to the creation of high quality documents supporting
changes to the CDS with internal and/or external experts including the preparation of
responses to labeling-related Health Authority queries.
• Global Labeling Committee (GLC): Present and defend proposed changes to global core
labeling documents, including labeling documents in key markets, to the GLC for review and
approval. Ensure that key country label proposals which deviate from a proposed CDS or
CDS amendment/update (e.g., US PI, EU SmPC) are brought to the attention of the GLC,
together with rationale.
Page 2 of 3
• Portfolio Stewardship Board (PSB): Support the Portfolio Stewardship process as a GL
representative by contributing to input impacting all labeling related topics and follow-up
activities for assigned marketed products.
Expert Labeling Task Forces (ELTF): Organize and lead cross functional ELTF meetings
(including experts from DRA, Clinical, DS&E, DMPK, PCS, Reg CMC, etc) to reach consensus
on global labeling matters, assess impact of regional/local labeling changes on the CDS, and
lead subject matter experts in the preparation of high-quality supporting documents for CDS
updates and amendments for assigned products. Lead ELTF meetings to review HA requested
labeling deviations and assist GPRD/GPRMs/DRA CPOs with the preparation of an
appropriate response document. Present HA-requested deviations with an impact on the CDS
to the GLC/PSB.
• Interactions with DRA worldwide: Interact with DRA Country Pharma Organizations (CPOs)
and regional GPRM/GMRMs to ensure timely implementation of global safety labeling
changes in local product information, international consistency with the company’s safety
position defined in the CDS, and compliance with local labeling regulations..
Posting Title

Global Labeling Manager - Regulatory Affairs

Desired profile

Minimum requirements

Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred English 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.
Job Type

Full Time
Country

USA
Work Location

East Hanover, NJ
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

REG AFFAIRS GDD
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.