Hub Labelling Manager – Regulatory Affairs | Pfizer | Mumbai, Chennai

Job Description

Manager – Regulatory, CMC Strategy, SI LCM

The Position:

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.

Responsibilities:

• 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 system. 
• Contributes to the completion of moderately complex projects under the direction of more senior labeling 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 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 as appropriate. 
• To support the 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 GRA’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 
• For deliverables in scope, prepare responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions, and represents Pfizer during HA Inspections

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 the use of systems consistent with business expectations, and understands the importance of systems in maintaining high compliance figures.
• Fluency in the English language important however multi-language skills are advantageous.
• Clear and effective written and verbal communication.
• 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.

Qualification:

• 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. 
• Demonstrated 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 abilities essential

Organizational Relationships:

• Reporting relationship to Regional Labeling Head and International Labeling Team Lead. 
• Partners with Pfizer PCOs, GRA groups, GRO groups, and other platform lines as required. 
• Supports global, GRA, GRO, and ILG initiatives as required.