The Global Labeling Lead (GLL) has overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. This includes guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents. This may also include Regulatory Authority driven documents such as the Core Safety Profile.
Life sciences, pharmacy graduate or equivalent.
Advanced academic qualifications/degree such as PhD an advantage but not essential.
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 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.
Experience and Attributes:
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); experiences of review and implications of the CDS 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.
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