
Atirah Alway
Scientific
About Atirah Alway:
Regulatory Affairs professional with over 8 years of experience in product registration, regulatory submission, compliance management, and government liaison across agrochemical, household insecticide, and consumer product industries. Strong expertise in Malaysian regulatory frameworks including the Pesticides Board, NPRA, MOH, with exposure to ASEAN and international standards. Proven track record in securing product approvals, managing labeling and safety compliance, and collaborating with government agencies such as MOH, DBKL, PKD, and local councils to support market access and product adoption. Recognized for regulatory accuracy, integrity, and strategic execution aligned with public health policies and corporate objectives.
Recently completed the Professional Certificate in Regulatory Affairs of Herbs, Supplements and Cosmetics (Universiti Kebangsaan Malaysia) strengthening regulatory competency in health-related consumer products.
Experience
Regulatory Affairs Responsibilities:
- Collaborate with Earth Corporation Japan and regional counterparts across Southeast Asia to align regulatory documentation and product compliance strategies.
- Develop, present, and oversee Regulatory Affairs (RA) budgets and resource planning to support compliance and product registration timelines.
- Lead regulatory affairs activities for new insecticide, cosmetic, and consumer product approvals, modifications, and renewals in accordance with Pesticides Board Malaysia and National Pharmaceutical Regulatory Agency (NPRA) requirements.
- Prepare and submit comprehensive regulatory dossiers, Safety Data Sheets (SDS), and product labelling, ensuring full compliance with local and international standards.
- Collaborate with R&D and HQ Japan to ensure safety, efficacy, and technical data for new formulations meet Malaysian and ASEAN regulatory expectations.
- Oversee the development of product-specific registration packages, including scientific data, efficacy trials, and toxicological assessments.
- Review and approve product labels, packaging, and advertising materials to ensure alignment with MOH and NPRA regulations.
- Maintain up-to-date knowledge of evolving Malaysian, ASEAN, and global regulatory frameworks to ensure continued product compliance and market readiness.
- Track and monitor submission progress, proactively resolving issues to meet regulatory and commercial launch deadlines.
- Train and mentor cross-functional teams on documentation, compliance standards, and regulatory best practices.
- Collaborate with logistics and supply chain teams to ensure smooth importation and customs clearance of regulated products.
- Liaise with GS1 Malaysia for barcode purchasing, registration, and internal approval prior to product launch.
Company Affairs Responsibilities:
- Advocate and influence government bodies, including the Ministry of Health (MOH) and Kuala Lumpur City Hall (DBKL), to support and adopt company products in public health initiatives and procurement programs.
- Establish and maintain strategic relationships with key government stakeholders, including the Ministry of Health (MOH), District Health Offices (PKD), hospitals, local authorities, and COMBI (Communication for Behavioural Impact) representatives.
- Plan, coordinate, and represent the company in government-led events, health campaigns, and exhibitions to promote product awareness and brand trust.
- Ensure alignment of company initiatives with public health policies and local authority guidelines.
- Spearhead government-related tenders and quotations, ensuring timely submissions and strategic alignment.
Education
Master of Environment (2019–2021) and Bachelor of Agriculture Science (2013–2017), Universiti Putra Malaysia. Completed an academic mobility semester at Universitas Sebelas Maret, Indonesia under the AIMS Programme sponsored by the Ministry of Higher Education Malaysia (2015). Also holds a Foundation in Agriculture Science (UPM, 2012–2013). Further strengthened regulatory expertise with a Professional Certificate in Regulatory Affairs of Herbs, Supplements and Cosmetics from Universiti Kebangsaan Malaysia (2026).
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