Associate Regulatory Labelling

Job Description

Associate Regulatory Labelling

Create and maintain global Reference Product Information/Company Core Data Sheets, based on scientific data, for mature products in

co-operation with the product teams as the basis for worldwide harmonized product labeling documents

Lead multi-discipline labeling teams, presenting labeling proposals and reaching consensus on proposals and presentation of labeling

proposals to Labeling Decision Board for internal approval of proposed labeling

Oversee and support implementation of Reference Product Information/Company Core Data Sheets into local/regional labeling

documents

Provide, upon request, analysis of competitor labeling in the relevant therapeutic area

Update labeling for mature products, resulting in completion of internal and external approved product labeling, including Corporate,

and EU CP and MRP/DCP labeling

Participate in labeling negotiations with regulatory agencies and review local labeling for consistency with corporate labeling

Monitor compliance of locally/regionally developed labeling documents for consistency with the Reference Product

Information/Company Core Data Sheet and timely submission of label (safety) changes.

Key objective of the role (as detailed as

possible)

1-Pharmacology

2-Knowledge in labelling(good to have)

3-Good Communication

Work Experience / Background 0-1 Years

Education / Qualifications required M.Pharm (Pharmacalogy)/Pharm.D