Senior Associate Hub Labeling Manager

Pfizer, S.A. de C.V; Kuala Lumpur; Hybrid; MYR 70,000 - 90,000; Full time

Job summary

A global pharmaceutical company in Kuala Lumpur is seeking a professional for a regulatory affairs role. The candidate will contribute to labeling projects, produce documentation for health authorities, and perform quality checks. A degree in life sciences or pharmacy is required, alongside strong communication skills. This role offers a hybrid work model and focuses on ensuring compliance with regulatory standards.

Benefits

Competitive compensation

Benefits programs

Qualifications

• Graduate in life sciences or pharmacy, or relevant professional experience.
• Demonstrated ability to develop positive working relationships across cultures.
• Ability to quickly learn regulations and standards.

Responsibilities

• Contribute to moderately complex projects under senior labeling managers.
• Produce labeling-related documentation for submission to HAs.
• Perform quality checks of colleagues’ work.

Skills

Basic knowledge of labeling principles

Knowledge of regulatory principles

Proficient in enterprise databases

Fluency in English

Effective communication skills

Attention to detail

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.

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.

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.

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.

Regulatory Affairs