About Us
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 eight 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 the 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
We are looking for an experienced Packaging Development Professional to drive packaging innovation, regulatory compliance, commercialization, artwork, and global product launches across a diverse portfolio of oral solids and injectables.
This is a high-impact managerial role working closely with R&D, Regulatory Affairs, Supply Chain, Manufacturing, Procurement, Quality, and Global Commercial teams to develop robust, compliant, patient-centric, and cost-effective packaging solutions for regulated and emerging markets.
Key Responsibilities:
- Lead development of primary, secondary, and tertiary packaging systems for regulated and emerging markets.
- Evaluate innovator and competitor packaging and define optimal packaging strategies.
- Drive packaging innovation, cost optimization, and lifecycle management initiatives.
- Support global dossier global submissions through packaging development reports and technical documentation.
- Respond to regulatory agency queries related to packaging materials, DMFs, extractables & leachables, and container closure systems.
- Ensure compliance with USP, EP, ASTM, ISO, GS1, serialization, and country-specific packaging requirements.
- Active participation in review and approval processes for artwork, cartons, labels, foils, inserts, leaflets, and shipper labels.
- Prepare and review technical documents including but not limited to Packaging Specifications, BOMs, Master Packaging Cards, Pack Profiles, STPs/GTPs , Packaging Development Reports, Packaging Summaries for Regulatory Filings
- Develop Keyline Drawings (KLDs) and manage artwork lifecycle through approved systems.
- Lead machine trials, packaging line qualification, change-part development, and packaging implementation activities.
- Troubleshoot packaging issues during exhibit, validation, and commercial batches.
- Support technology transfers, site transfers, and global launch activities.
- Develop and qualify packaging suppliers and alternative sourcing strategies.
- Collaborate with Procurement, QA, Manufacturing, Regulatory Affairs, Supply Chain, and Business Development teams.
- Drive vendor performance, cost reduction, and supply continuity initiatives.
About You
- Bachelor's or Master's degree in Pharmacy, Packaging Technology, Engineering, or related discipline.
- Post Graduate Diploma in Packaging Technology preferred.
- 7+ years of pharmaceutical packaging development experience.
- Strong experience across USFDA, EU, MHRA, WHO, and ROW markets.
- Experience handling OSD and Injectables.
- Knowledgeable on packaging characterization and innovator benchmarking.
- Has experience with container closure systems, blisters, bottles, vials, ampoules, syringes, laminates, labels, cartons, leaflets, shippers, and pallets.
- Good knowledge on Serialization, Track & Trace, GTIN, GS1 Barcoding.
- Packaging line equipment and automation.
- Extractables & Leachables assessments.
- Vendor qualification and packaging material procurement.
- Packaging testing aligned with USP, ASTM, ISO, and global standards.
