Minimum requirements:
Education:
- Life sciences, pharmacy graduate or equivalent
- Advanced academic qualifications/degree such as PhD an advantage but not essential

Experience:
- Significant ‘hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products), preferably from the perspective of a country office or regional regulatory strategy environment advantageous, especially with the perspective of the implications of core content on the PI and PIL
- Proven ability to successfully understand regulatory implications of product strategy with regard to producing the label, assessment and practical management of associated impacts
- Demonstrated ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post-approval (maintenance) stages
- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
- Knowledge of global/regional regulatory guidelines and requirements is important
- Knowledge of Clinical variations preferred
- Proven strength in logical, analytical and writing ability essential
- Readability testing knowledge an advantage but not essential
- Demonstrated project management, attention to detail and problem solving skills required

Technical skills:
- Has thorough knowledge of the principles, concepts and theories of labeling, and awareness of principles and concepts of other labeling-related disciplines
- Understands and applies labeling regulation knowledge in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text
- Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures
- Fluency in English language important however multi-language skills are advantageous
- Written and verbal communications clear and effective
- Understands and applies labeling regulation in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text