Global Lead, Formulation (OSD) & Regulatory Strategy

NOVUGEN PHARMA (MALAYSIA) SDN. BHD.; Shah Alam; On-site; MYR 110,000 - 170,000; Full time

Job summary

Novugen Pharma (Malaysia) Sdn. Bhd. is seeking an Associate Manager, Formulation to ensure quality and regulatory compliance through development of oral solid dosage forms for regulated and semi-regulated markets.

The role will supervise formulation scientists, oversee PDPs, stability compilations and be involved in regulatory submissions and tech transfer. The ideal candidate has 6–10 years in pharma, with 2–3 years of supervisory experience and a strong track record in US/EU dossier

Qualifications

• 6–10 years in pharma with OSD formulation experience.
• 2–3 years of supervisory experience.
• Experience developing formulations for regulated markets (US, EU).

Responsibilities

• Lead a team of formulation scientists and lab staff to deliver development projects.
• Oversee literature surveys, patent searches, PDPs and regulatory documents.
• Review analytical results and guide product development decisions with minimal supervision.
• Coordinate development of tablets, capsules and other solid dosage forms.
• Support regulatory submissions and GMP-compliant transfer activities.

Skills

Formulation

Leadership

Regulatory filing

Quality control

Project management

Cross-functional

Job description

Novugen Pharma (Malaysia) Sdn. Bhd. is seeking an Associate Manager, Formulation to ensure quality and regulatory compliance through development of oral solid dosage forms for regulated and semi-regulated markets.

The role will supervise formulation scientists, oversee PDPs, stability compilations and be involved in regulatory submissions and tech transfer. The ideal candidate has 6–10 years in pharma, with 2–3 years of supervisory experience and a strong track record in US/EU dossier