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Regulatory Hub Labelling Manager

3 months ago

Tadworth, United Kingdom SRG Full time

JOB SUMMARY

Manager Is responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products for their assigned markets and updating the labelling 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 labelling requirements and participate in the sharing of intelligence in collaboration with other Hub Labelling 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

 Supports Hub Labelling Manager (Manager) by maintaining system management for labelling activities including Global Document Management System (GDMS) and Pfizer approved labelling tracking system.

Maintenance of workflow management tools and mailboxes.

 Provides ad hoc support for labelling deliverables.

 Performs QC of labelling text.

 Monitors system data integrity and quality checks.

 To maintain system management for labelling activities including GDMS and Pfizer approved labelling tracking system.

Senior Associate (cumulative from above)  Contributes to the completion of moderately complex projects under the direction of more senior labelling managers.

 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 labelling-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 labelling-related processes and systems for exploration by more senior labelling managers.

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

Manager (cumulative from above)

 To utilize regulatory labelling expertise to review, develop and deliver labelling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate.

 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 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 labelling data analysis.

 To create or enhance SharePoint web pages.

 The full range of labelling 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

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.


SKILLS

 Basic knowledge/understanding of the principles and concepts of labelling.

 Basic knowledge of key regulatory and labelling 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.


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.

 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 labelling 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 (preferred)