Senior Executive, Regulatory Affairs

Novugen; Shah Alam; On-site; MYR 120,000 - 180,000; Full time

Job summary

Novugen is seeking a Regulatory Affairs specialist to navigate the dynamic regulatory landscape in Malaysia and influence the registration and launch of products within the market.

You will join a fast-growing pharmaceutical company that values scientific excellence, collaboration, and global impact, contributing to life-science developments and product approvals.

Qualifications

• Bachelor’s degree in pharmacy, Life Sciences, or related scientific field.
• 3–5 years of hands-on experience in pharmaceutical regulatory affairs.
• Proven experience preparing and submitting registration dossiers to NPRA.
• Strong understanding of Malaysian regulatory requirements and ACTD/CTD.

Responsibilities

• Lead preparation, review, and submission of regulatory dossiers (new registrations, variations, renewals) meeting NPRA requirements.
• Develop and implement regulatory strategies with cross-functional teams for timely approvals and lifecycle management.
• Interpret and communicate regulatory guidelines to cross-functional teams throughout development and commercialization.
• Manage regulatory commitments, timelines, and responses to authority queries to ensure on-time completion.
• Review product artwork, labeling, and promotional materials for regulatory consistency.

Skills

Regulatory affairs

Regulatory strategy

Communication skills

Education

Bachelor’s degree in pharmacy/Life Sciences

Job description

Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market.

Our manufacturing facilities in Bandar Enstek, Negeri Sembilan, are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards.

At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impacting lives across the world.

Together, we are shaping the future of healthcare and changing lives everywhere.

About the Role

As a key member of our Regulatory Affairs team, you will help navigate the dynamic regulatory landscape in Malaysia, directly influencing the company’s ability to register and launch products in the market. This role provides an opportunity to be part of a dynamic, fast-growing pharmaceutical company that values scientific excellence, collaboration, and global impact.

Key Responsibilities:

• Lead the preparation, review, and submission of regulatory dossiers (new registrations, variations, renewals) in compliance with NPRA requirements.
• Develop and implement regulatory strategies in collaboration with cross-functional teams to ensure timely product approvals and effective life-cycle management.
• Evaluate and interpret regulatory guidelines and communicate their implications to cross-functional teams, ensuring compliance throughout product development and commercialization.
• Manage and track regulatory commitments, timelines, and responses to authority queries to ensure efficient follow-up and on-time completion.
• Review product artwork, labelling, and promotional materials to ensure alignment with approved regulatory information.

About You

• Bachelor’s degree in pharmacy, Life Sciences, or a related scientific field.
• A minimum of 3-5 years of hands-on experience in pharmaceutical regulatory affairs.
• Proven expertise in preparing and submitting registration dossiers to the National Pharmaceutical Regulatory Agency (NPRA).
• Strong understanding of Malaysian regulatory requirements and dossier formats (ACTD/CTD).
• Demonstrated experience managing generic, biologic, or complex formulation submissions.
• Excellent written and verbal communication skills, with a keen eye for detail and accuracy.