Key Stakeholders:

Internal: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Management
External: Country Distributors, Health Authorities (HAs), Contract Manufacturing Organizations (CMOs), and external partners

Reporting Structure:

Reports to the Regulatory Affairs Labeling Manager

Experience:

4 years of relevant regulatory experience, with a preference for global experience in US, EU, and major Rest of World markets.

Competencies:

Strong interpersonal and organizational skills for effective collaboration.
In-depth knowledge of Health Authority labeling regulations and requirements.
Self-motivated, organized, and adaptable with a high level of accountability.
Excellent work ethic with a positive, proactive attitude in a dynamic environment.
Project management skills are advantageous.

Key Responsibilities:

Manage global labeling details, including labels, cartons, package inserts, and patient package inserts to ensure compliance, quality, and accuracy. Collaborate with cross-functional teams for regulatory submissions, evaluations, and approvals.
Prepare labeling-related documents, such as SmPC, PIL, and other texts for EU submissions.
Coordinate with stakeholders to ensure timely submission and approval of labeling, and address any related queries.
Proofread all types of label copy and annotations at various developmental stages to ensure accuracy.
Create Structured Product Labeling (SPL) for US Human and Veterinary product submissions, including drug listings, annual establishment registration, and GDUFA self-identification.
Monitor and process innovator-labeling updates for existing generic products, ensuring compliance with innovator updates through side-by-side comparisons with reference listed drugs (RLDs).
Oversee the development and updates of Core Data Sheets (CCDS) for PCC products and manage local labeling updates.
Contribute to the development and review of labeling aspects in promotional materials.
Develop and maintain a central repository for all labeling components.

Qualifications:

B.Pharm or M.Pharm

Senior Executive