Ain Nashwa Md Aszman
Regulatory Affairs Executive
Klang,10
Summary
Detail-driven and great accountability candidate eager to leverage extensive experience and expertise in regulatory affairs. Ready to drive successful registration of medical devices, ensuring compliance with MDA and NPRA as well as global regulations and standards. Proficient in contributing cross-functional collaboration, and regulatory intelligence to facilitate expedited market access and uphold product quality, compliance, and safety.
Overview
5
5
years of professional experience
19
19
years of post-secondary education
2
2
Languages
Work History
Regulatory Compliance Officer
SPD SCIENTIFIC (M) SDN BHD
08.2021 - Current
- Regulatory Compliance Management: Managed business permit and licenses applications, renewals, and amendments, ensuring adherence to regulatory requirements.
- Product Registration and Maintenance: Played a pivotal role in registering, renewing, and amending product registrations for various categories including Medical Devices, Pharmaceutical Poison Items, etc. Collaborated with stakeholders and regulatory authorities to ensure compliance.
- Regulatory Filings: Prepared, submitted, and maintained regulatory filings in a timely manner, ensuring compliance with regulatory deadlines and requirements.
- Documentation and Procedures: Developed, reviewed, and updated manuals and procedures in alignment with international and local regulations.
- Pharmacovigilance (PV) Responsibilities: Conducted PV training, literature screening, and provided updates to stakeholders. Acted as Deputy National Responsible Person for Pharmacovigilance (DNRPP) when required by local PV legislation.
- Compliance Process Optimization: Streamlined compliance processes by creating efficient systems for managing documentation and reporting requirements, enhancing overall compliance efficiency.
- Regulatory Audits: Played a key role in successfully completing regulatory audits by providing necessary documentation and addressing concerns raised by auditors.
RA cum QA/QC Executive
UNIVERSITI PUTRA MALAYSIA AMLION TOOTHPASTE MFG SDN BHD
01.2020 - 07.2021
- Regulatory Affairs Management: Handled regulatory affairs matters concerning various government bodies such as JAIS, JAKIM, NPRA, foreign embassies, and the FDA, particularly focusing on product registration and compliance within specified timelines.
- Liaison and Negotiation: Acted as a liaison and negotiated with different parties to ensure successful product notification and registration, demonstrating strong communication and negotiation skills.
- Audits and Quality Assurance: Participated in third-party/governmental audits as well as customer audits. Conducted quality audits of all activities and ensured implementation of corrective actions. Provided support to achieve and implement quality standards.
- Halal Compliance: Served as a member of the internal Halal committee, fulfilling roles as a Halal Executive, coordinator, and auditor. Certified as a Halal Executive by JAKIM, demonstrating expertise in ensuring compliance with Halal requirements.
QA Lab
VITAL HEALTHCARE SDN BHD
05.2019 - 01.2020
- Water Treatment Plant Quality Management: Held responsibility for ensuring the quality of water treatment plants specifically tailored for GMP (Good Manufacturing Practices) and healthcare facilities, emphasizing compliance with relevant regulations and standards.
- Environmental Quality Monitoring: Monitored various aspects of environmental quality within GMP facilities, including finger bacteria, sentimental bacteria, air change rate, compressed air, and different pressure levels, aiming to maintain optimal environmental conditions conducive to manufacturing processes.
- Documentation and Audit Preparation: Prepared and updated documentation required for audits, demonstrating meticulous attention to detail and adherence to regulatory requirements. Ensured that all documentation related to GMP cleanliness, sanitization, housekeeping, and pest control was up-to-date and compliant.
- Daily Inspection and Compliance Oversight: Conducted daily inspections of GMP cleanliness, sanitization practices, housekeeping standards, and pest control measures, proactively identifying and addressing any compliance issues to maintain high standards of facility cleanliness and regulatory compliance.
- Training and Certification: Participated in a Training Course for Internal Auditor (ISO 13485:2016), indicating a commitment to professional development and enhancing expertise in quality management systems relevant to medical devices.
Education
Bachelor of Science - Biotechnology
UNIVERSITI PUTRA MALAYSIA
Serdang, Selangor 01.2015 - 08.2018
Associate of Applied Science - Foundation of Agricultural Science
UNIVERSITI PUTRA MALAYSIA
Serdang, Selangor 06.2013 - 07.2024
High School Diploma -
SEKOLAH MENENGAH SAINS TENGKU ABDULLAH
Raub, Pahang 10.2008 - 12.2012
Skills
Regulatory Compliance Knowledge: Understanding of relevant regulations, standards, and guidelines governing medical devices, cosmetics, and Halal products
Documentation Management: Ability to prepare, review, and maintain regulatory documentation, ensuring accuracy and compliance with regulatory requirements
Communication Skills: Strong written and verbal communication skills to effectively communicate with regulatory authorities, internal stakeholders, external partners, and customers regarding regulatory requirements, submissions, and compliance issues
Attention to Detail: Meticulous attention to detail to ensure accuracy in regulatory submissions, documentation, and compliance activities, minimizing the risk of errors and non-compliance
Problem-Solving Abilities: Analytical and problem-solving skills to identify regulatory issues, assess potential risks, and develop strategies to address compliance challenges or obstacles effectively
Cross-Functional Collaboration: Collaboration skills to work effectively with cross-functional teams to ensure alignment and integration of regulatory requirements throughout the product lifecycle
Accomplishments
- Submitted over 10 Special Access applications for Covid test kits during the pandemic without prior knowledge, ensuring timely access to critical medical resources.
- Managed and led the submission of Notifications for Hand Sanitizer during the pandemic.
- Conducted meetings with NPRA officers to address and resolve issues, demonstrating proactive problem-solving skills and regulatory compliance expertise.
Timeline
Regulatory Compliance Officer
SPD SCIENTIFIC (M) SDN BHD
08.2021 - Current
RA cum QA/QC Executive
UNIVERSITI PUTRA MALAYSIA AMLION TOOTHPASTE MFG SDN BHD
01.2020 - 07.2021
QA Lab
VITAL HEALTHCARE SDN BHD
05.2019 - 01.2020
Bachelor of Science - Biotechnology
UNIVERSITI PUTRA MALAYSIA
01.2015 - 08.2018
Associate of Applied Science - Foundation of Agricultural Science
UNIVERSITI PUTRA MALAYSIA
06.2013 - 07.2024
High School Diploma -
SEKOLAH MENENGAH SAINS TENGKU ABDULLAH
10.2008 - 12.2012
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