Global Labeling Lead
Day-to-day direction to Labeling Operations Specialists so that labeling and decision documents
can be prepared and managed appropriately throughout processes and systems.
The GLL also interfaces with Hub Labeling Managers and PCO colleagues to support timely and
quality submissions globally.
? 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.
? Life sciences, pharmacy graduate or equivalent.
? Advanced academic qualifications/degree such as PhD an advantage but not essential.
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
? Proven understanding of the dynamics and purpose of company CDS/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
? Demonstrated ability to develop strong and positive working relationships across multiple cultures
? Understanding of regulatory authority philosophy and expectations.
? Knowledge of global/regional regulatory guidelines and requirements important.
? Excellent written and verbal communication skills essential.
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