Senior Executive

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