Hub Labeling Manager (Manager)

JOB TITLE: Hub Labeling Manager (Manager)

REPORTS TO: Team Lead, Hub Labeling Manager

DIVISION/BUSINESS LINE:

Pfizer Research & Development (PRD)

VERSION DATE:16-Aug-2023

SUB DIVISION:International Labeling & Artwork (ILA)

DEPARTMENT NAME:Global Regulatory Sciences (GRS)

LOCATION:Egypt, Cairo

LEVEL:Manager(Grade: GJL070)

JOB SUMMARY

The HLM (Manager) is 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

· To utilize 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.

· Performs QC check of labeling text.

· Maintains system management for labeling activities including GDMS and Pfizer approved labeling tracking system.

· Monitors system data integrity and quality checks.

· To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing.

· Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.

· To work 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.

· To take part in research incubator work leveraging technologies in process automation, machine-learning, business process management etc.

· To work 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.

· To assist with labeling data analysis.

· To create or enhance SharePoint web pages.

· The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as complex revisions.

· Meets defined targets on productivity, quality and compliance, as set by and overseen by management

· For deliverables in scope, prepares responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions, and represents Pfizer during HA Inspections

QUALIFICATIONS / SKILLS

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.

· Fluency (written and spoken) in English language required, however multi-language skills are preferred such as the ability to QC check scientific/medical content in Arabic in line with reference label text.

· Clear and effective written and verbal communications.

· Understanding of the importance of SOPs, systems and processes in underpinning quality and compliance of deliverables.

· Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access.

QUALIFICATIONS

· Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience

EXPERIENCE

· Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations is preferred.

· 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.

· Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs; from the perspective of a Country office or Regional Regulatory Strategy is important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs.

· 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 is preferred.

· Demonstrated project management, attention to detail and problem-solving skills is required.

· Proven strength in logical, analytical and writing ability is essential.

ORGANIZATIONAL RELATIONSHIPS

· Reporting relationship to International Labeling Team Lead.

· Partners with CRSs, GRS groups, ILA groups and other platform lines as required.

· Supports global, GRS and ILA initiatives as required.

 
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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Regulatory Affairs