Hub labeling manager - #505320
This position 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.
Supports other Hub Labeling Manager (Manager) by maintaining system management for labeling activities
including Global Document Management System (GDMS) and Pfizer approved labeling tracking system.
Maintenance of workflow management tools and mailboxes.
Provides ad hoc support for labeling deliverables.
Performs QC of labeling text.
Monitors system data integrity and quality checks.
To maintain system management for labeling activities including GDMS and Pfizer approved labeling tracking
Contributes to the completion of moderately complex projects under the direction of more senior labeling
Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs where there are unambiguous
relationships to source documents and clear local regulatory principles to follow, requesting advice or input
from other functions when appropriate.
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.
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
To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing.
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 RD lead(s) with digital transformation project activities, to transform regulatory data, systems
and processes into an integrated, hyper efficient learning platform, corresponding to GRA s overarching
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
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
The candidates who have India/Indian region(Bangladesh, Sri Lanka, Bhutan, Nepal)/Pakistan local regulatory affairs experience and knowledge.
Basic knowledge/understanding of the principles and concepts of labeling.
Basic 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 language important however multi-language skills are advantageous.
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.
Knowledge of key regulatory and labeling principles and local regulations.
Strong knowledge/understanding of the principles and concepts of labeling.
Strong knowledge of key regulatory and labeling principles and local regulations.
Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
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.
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.
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.
Demonstrated project management, attention to detail and problem-solving skills.
Proven strength in logical, analytical and writing ability essential
Reporting relationship to Regional Labeling Head and International Labeling Team Lead.
Partners with Pfizer PCO s, GRA groups, GRO groups and other platform lines as required.
Supports global, GRA, GRO and ILG initiatives as required.