Hub Labeling Manager

The HUB Labeling Manager will be responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products for their assigned markets and updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements. This role may act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence in collaboration with other Hub Labeling Managers. Additionally, this role will serve as an SME for the use and development of current and new global tools, technologies and processes to support label development, submission and approval; with a particular focus on digital solutions.

JOB RESPONSIBILITIES

• Maintains system management for labeling activities including Global Document Management System (GDMS) and client approved labeling tracking system.
• Maintenance of workflow management tools and mailboxes.
• Monitors system data integrity and quality checks.
• Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs.
• Produces other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supporting documentation.
• Performs QC check of other colleagues’ work.
• 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.
• Utilizes regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate.
• Supports provision of other deliverables within the scope of ILG responsibilities e.g. readability testing.
• Works on projects involving the use of current and new global tools, technology and processes to support label development, submission and approval; with a particular focus on digital solutions.
• Takes part in research incubator work leveraging technologies in process automation, machine-learning, business process management etc.
• Works with R&D lead(s) with digital transformation project activities, to transform regulatory data, systems and processes into an integrated, hyper efficient learning platform, corresponding to GRS’s overarching roadmap.
• Assists with labeling data analysis.
• Creates or enhances SharePoint web pages.
• The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as complex revisions.
• For deliverables in scope, prepares responses to inquiries from client colleagues in response to inspection activities and regulatory agency questions, and represents client during HA Inspections.

QUALIFICATIONS

• Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
• Fluency in English language important however multi-language skills are advantageous.
• Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access.
• Knowledge of key regulatory and labeling principles and local regulations.
• ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs; preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs.
• Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
• Demonstration of attention to detail and problem-solving skills.
• Proven technical aptitude and ability to quickly learn new software.
• Proven technical aptitude and ability to quickly learn regulations and standards.
• Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label.
• Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important.
• 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 preferred.
• Demonstrated project management, attention to detail and problem-solving skills.
• Proven strength in logical, analytical and writing ability essential.

SKILLS

• 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.
• Clear and effective written and verbal communications.
• Understanding of the importance of SOPs, systems and processes in underpinning quality and compliance of deliverables.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.