Global Formulation Manager – OSD Development & Compliance

NOVUGEN PHARMA (MALAYSIA) SDN. BHD.; Shah Alam; On-site; MYR 180,000 - 240,000; Full time

Job summary

NOVUGEN PHARMA (MALAYSIA) SDN. BHD. is seeking an Associate Manager, Formulation to lead a team of scientists in developing oral solid dosage forms for regulated and semi-regulated markets.

You will guide development programs, ensure regulatory readiness, and drive cross-functional collaboration. The role emphasizes QbD-based development, literature surveys, technology transfer, and strong interaction with Management to advance innovative products while ensuring GMP compliance and timely

Qualifications

• 6–10 years of pharma experience with OSD formulation.
• 2–3 years of supervisory experience.
• Experience developing formulations for regulated & semi-regulated markets.
• Understanding regulatory guidelines for dossier preparation and submission in US, EU and global markets.
• Knowledge of pharmacokinetics & biopharmaceutical aspects of product development.
• Strong project management skills.
• Proficient with Microsoft Office and pharma systems.
• Ability to work under pressure and manage stakeholders.

Responsibilities

• Supervise and lead a team of formulation scientists and lab technicians, providing coaching and mentoring.
• Oversee literature survey, patent search, online documentation, design, development & execution of developmental batches.
• Prepare Product Development Plans (PDP), Stability compilations, and Product Development Reports for regulatory submission.
• Review analytical results and guide decision-making for product development with minimal supervision.
• Review trial batches for tablets, capsules & other solid oral dosage forms for global filings following QbD.
• Support process development and technology transfer activities and risk mitigation for product life cycle management.
• Coordinate with Scientific Operations, Manufacturing and Quality Control to support development and commercialization.
• Maintain awareness of industry trends and regulatory changes to drive continuous improvement.

Skills

OSD formulation

Supervisory experience

Regulatory guidance

Pharmacokinetics

Biopharmaceutical principles

Project management

Microsoft Office

GMP awareness

Stakeholder management

Job description

NOVUGEN PHARMA (MALAYSIA) SDN. BHD. is seeking an Associate Manager, Formulation to lead a team of scientists in developing oral solid dosage forms for regulated and semi-regulated markets.

You will guide development programs, ensure regulatory readiness, and drive cross-functional collaboration. The role emphasizes QbD-based development, literature surveys, technology transfer, and strong interaction with Management to advance innovative products while ensuring GMP compliance and timely