Hub Labeling Manager

Pfizer Türkiye

Position Purpose

The Hub Labeling Manager (HLM) is responsible for preparing local product labelingdocuments and their associated local language labeling documents for the Eurasian Economic Union (EAEU), and other markets.  The HLM is also responsible for updating the labeling documents on a timelybasis according to internalSOPs and external regulatoryrequirements. 

This position may support other HLMs and will collaborate with Regulatory and Medical leaders based in various countries including UK, USA, Russia and other EAEU countries.

This position will act as a Subject Matter Expert (SME) on local, regional and multi country regulatory labelling requirements and participate in the sharing of intelligence.

Primary Responsibilities

The HLM is responsible for the delivery and management of labeling text through the appropriate processes and systems, and through interaction with colleagues in other roles. 

Key activities include:

The HLM is responsible for the delivery and management of labeling text through the appropriate processes and systems, and through interaction with colleagues in other roles. 

• Utilization of regulatory expertise and analytical skills to review and develop appropriate content for local labeling documents based on existing approved content, seeking strategic and medical input from others as required, and recording any decisions made.
• Communication, planning, prioritization and delivery of labeling documents according to company targets and submission requirements.
• Answering queries from client colleagues in response to inspection activities and regulatory agency questions.
• Liaison with stakeholders using the most effective means of communication; presentation of information in an optimal format and level of information for that audience.
• Ongoing development of labeling and subject matter expertise for assigned markets; the focus is expected to be on EAEU markets.
• Working within a framework of internal standard operating procedures (SOPs), working practices, and external regulatory requirements, so that the high-quality delivery of outputs and compliance is maintained.
• Appropriately tracking labelling projects via defined procedures and systems.
• Ensuring that decisions taken for labelling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely manner.
• Supporting the use of relevant tools and technologies within the course of the label development and translation process.

Technical Skill Requirements

• Knowledge of regional regulatory regulations and guidelines pertaining to labeling, and/or general regulatorybackground/experience, potentiallygained in a countryoffice environment,is preferred.
• Ability to understand, analyze and propose information to be included in local labeling documents and the abilityto logicallyreviewany impact on othersections of the same documentation.
• Ability to delegate work to others, including working with internal and external vendors

Qualifications

• 1 year of pharmaceutical experience
• Experience of working within corporate systems and procedures
• Experience of delegating work to others or working with vendors
• Written and verbal communications should be clear and effective; fluency in English and Russian
• Excellent project management skills, and ability to plan, prioritize and deliver within specific deadlines