Senior Associate Hub Labeling Manager

Pfizer, S.A. de C.V; Kuala Lumpur; Hybrid; MYR 60,000 - 90,000; Full time

Job summary

A global pharmaceutical company is seeking a regulatory affairs professional to manage labeling documentation and contribute to complex projects. The role requires a life sciences or pharmacy graduate with knowledge in regulatory principles, effective communication skills, and experience with structured data. The position offers a hybrid work model, promoting a collaborative environment across cultures.

Benefits

Competitive compensation and benefits

Qualifications

• Basic knowledge of labeling concepts and regulatory principles is essential.
• Fluency in English and additional languages is advantageous.
• Experience with structured data is required.

Responsibilities

• Contribute to moderately complex projects with senior managers.
• Produce labeling documentation for submission to health authorities.
• Perform quality checks on colleagues’ work.

Skills

Knowledge of key regulatory and labeling principles

Proficient in enterprise databases and MS Excel

Clear and effective written and verbal communications

Basic understanding of labeling principles and concepts

Education

Life sciences or pharmacy graduate

Tools

MS Excel

MS SharePoint

MS Access

Job description

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Responsibilities

• 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.

Skills

• Basic knowledge/understanding of the principles and concepts of labeling.
• 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.

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. (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; 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. (Preferred)
• Demonstrated project management, attention to detail and problem-solving skills. (Preferred)
• Proven strength in logical, analytical and writing ability essential

Job Responsibilities

• 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.

Work Location

Hybrid

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