Senior Labeling Lead
7 days left
- Experience Level
- Experienced (non-manager)
- Life sciences, pharmacy graduate or equivalent.
- Advanced academic qualifications/degree such as PhD an advantage but not essential.
- Minimum 7 to8 yrs of relevant experience in Strategic/Global labeling
Significant 'hands on' registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); Perspective from HQ, Country office and/or Regional Regulatory Strategy (at a global/multi-national pharmaceutical environment) necessary. Experience at the country level important and advantageous.
- Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS), Core Safety Information (CSI); experiences of review and implications of the CDS/CSI an advantage.
- Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
- Demonstrated ability to interpret and apply global and 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.
- Understanding of regulatory authority philosophy and expectations.
- Knowledge of global/regional regulatory guidelines and requirements important.
- Excellent written and verbal communication skills essential.
- Complete Fluency in English Language.
- Proven strength in logical, analytical and writing ability essential.
- Demonstrated project management skills and attention to detail required.
- Proven ability to negotiate, influence and problem solve.
- Knowledge of global/regional regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels across the regions.
- Demonstrated knowledge and understanding of company Core Data Sheets, Core Safety Information documents and the dynamics of Labeling Team purpose and objectives.
- Demonstrated ability to understand how updating one section of a label may impact another and to propose recommendations to the Labeling Team.
- Fluency in English language important; multi-language skills are advantageous.
- Clear and effective written and verbal communication skills. Ability to liaise with stakeholders using effective means of communication. Demonstrated ability to influence and negotiate where necessary, across a highly matrixed team.
- Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
- Ability to interact effectively with all levels/roles of project team members.
- Handled Development product labeling updates