Organizational Relationship(s) including to whom the position reports (JD Job Title):

This position reports to the locally based Regional Labeling Head, International Labeling Team Lead, or to a Senior Manager in International Labeling Group.

Position Purpose

The Hub Labeling Senior Associate level, is responsible for executing the content management of non-complex local product documents (LPDs), Local Label Documents (LLDs) and Patient Leaflets for nationally registered products for their assigned products across multiple countries/regions. The Hub Labeling Senior associate also provides support to the rest of the ILG organization

Primary Responsibilities

• Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.
• Utilize regulatory knowledge to produce noncomplex LPDs, LLDs and Patient Leaflets where there are unambiguous relationships to source documents and clear local regulatory principles to follow, requesting advice or input from other functions when appropriate.
• Production of other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supportive documentation.
• Provides QC support to other labeling colleagues.
• Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
• Meets defined targets on productivity, quality and compliance, as set by and overseen by management

• Strong knowledge/understanding of the principles and concepts of labeling.
• Strong knowledge of key regulatory and labeling principles and local regulations

• Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures

• Fluency in English and Spanish languages
• Clear and effective written and verbal communications

• Understanding of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverables

• Life sciences, pharmacy graduate or equivalent (desirable); or equivalent relevant professional experience.
• '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 important and advantageous especially with the perspective of the implications of a CDS on LPDs
• Ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impacts is preferable
• 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 is preferable
• Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
• Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important
• Demonstrated project management, attention to detail and problem solving skills required.
• Proven technical aptitude and ability to quickly learn new software, regulations and standards.