Regulatory Affairs Manager; Labeling

Job Description Summary

-Provides the labeling/artwork strategy, regulatory intelligence and knowledge which are required to develop, market, and maintain products. Provides strategic labeling input and support for global development projects and/or marketed products. Reviews labeling change information, and ensures that it is supported by the data and consistent with the application. Supports and assists the development and participates in negotiations on later stage products with regulatory agencies on approval of label. Monitors, evaluates and recommends improvements to labeling processes, quality, systems tools and/or policies.

Job Description

Major accountabilities:

• 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 DRA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products.
• Contribute to the creation of high quality documents supporting changes with internal and/or external experts including the preparation of responses to labeling related Health Authority queries -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 -A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
• Networks with senior internal and external personnel in own area of expertise.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Adherence to Novartis policy and guidelines -Project stakeholder feedback

Minimum Requirements:
Work Experience:

• Cross Cultural Experience.
• People Challenges.
• Functional Breadth.
• Project Management.
• Collaborating across boundaries.

Skills:

• Cross-Functional Teams.
• Detail Oriented.
• Labeling Documentation.
• Labeling Regulations.
• Operational Excellence.
• Regulatory Compliance.
• Safety.

Languages :

• English.

Skills Desired

Cross-Functional Teams, Detail-Oriented, Labeling Documentation, Labeling Regulations, Operational Excellence, Regulatory Compliance, Safety