Regulatory Affairs - Senior Specialist

Biomed Global; Petaling Jaya; Sur place; MYR 90 000 - 150 000; Plein temps

Résumé du poste

Biomed Global in Malaysia is seeking a Regulatory Affairs professional to maintain compliance across multiple marketing territories. You will manage pre-market registrations, changes, post-market reporting, and labeling with keen attention to local regulations.

You will coordinate internal and external audits, liaise with authorities, and support ERP updates for product compliance databases, ensuring timely and accurate regulatory submissions.

Qualifications

• Proactive, high performance, result oriented and manage projects with ethical integrity.
• Excellent written and verbal communication skills with the ability to listen, articulate and advocate.
• Possess good communication skills and ability to liaise with authorities, consultants, auditors and foreign manufacturers.
• Scientific knowledge with ability to digest complex data while keeping the big picture through strong analytical skills.
• Technical system skills (e.g. MS Office applications, databases, online research).
• Good organizational skills, meticulous planning and presentation skills.
• Demonstrate both creative and critical thinking skills.
• Good understanding of processes/workflows, keen to innovate and improve.

Responsabilités

• Stay up to date with the Regulatory landscape in each Marketing Territory.
• Independently ensure products compliance with applicable statutory and regulatory requirements by assessing, planning and executing Pre-market registration, Change notification, Special Authorization / Exemption Applications.
• Independently execute Post Market reporting timely and fulfill necessary requirements as part of post-market surveillance in documents and records keeping.
• Maintain compliance to advertisement regulations and respective labeling requirements in each marketing territory.
• Independently execute other authorities compliances with relevant authorities / government bodies such as Poisons (MOH MY, HSA SG), Flammables & Hazardous Substance (HS) (NEA SG); SIRIM/ IMDA (MY; SG); DVS/ AVS (MY; SG).
• Independently execute yearly RA Audits internally and document findings effectively.
• Support external regulatory agency audits/ Principal audits/ Supplier audits, providing regulatory input to minimize potential for findings of non-compliance.
• Support internal audits of respective subsidiaries and associated companies in South East Asia on Regulatory matters.
• Support routine Product Compliance Status (MDA, HSA, Other Authorities) Updates into ERP Systems, Verifying Product Compliances, updating product master list, IT batch uploads and logistic uploads for MDA Labeling database.
• Support Routine Updating of Registration master list (Regulatory Database).
• Actively participate in regulatory projects and provide inputs to process improvement.

Connaissances

Regulatory knowledge

Communication skills

Analytical thinking

Planning and organization

Project management

Liaising with authorities

Ethical integrity

Regulatory trend awareness

Outils

MS Office

Description du poste

• Stay up to date with the Regulatory landscape in each Marketing Territory.
• Independently and consistently ensure products compliance with applicable statutory and regulatory requirements by assessing, planning and executing Pre-market registration, Change notification, Special Authorization / Exemption Applications.
• Independently execute Post Market reporting timely and fulfill necessary requirements as part of post-market surveillance in documents and records keeping .
• Able to maintain compliance to advertisement regulations and respective labeling requirements in each marketing territory.
• Independently execute Other Authorities Compliances with relevant authorities / government bodies such as Poisons (MOH MY, HSA SG), Flammables & Hazardous Substance (HS) (NEA SG); SIRIM/ IMDA (MY; SG); DVS/ AVS (MY; SG).
• Independently execute yearly RA Audits internally and document findings effectively.
• Support external regulatory agency audits/ Principal audits/ Supplier audits, providing regulatory input to minimize potential for findings of non-compliance.
• Support internal audits of respective subsidiaries and associated companies in South East Asia on Regulatory matters.
• Support Routine Product Compliance Status (MDA, HSA, Other Authorities) Updates into ERP Systems, Verifying Product Compliances, updating product master list, IT batch uploads and logistic uploads for MDA Labeling database.
• Support Routine Updating of Registration master list (Regulatory Database).
• Actively participate in regulatory projects and provide inputs to process improvement.

• Stay up to date with the Regulatory landscape in each Marketing Territory.
• Independently and consistently ensure products compliance with applicable statutory and regulatory requirements by assessing, planning and executing Pre-market registration, Change notification, Special Authorization / Exemption Applications.
• Independently execute Post Market reporting timely and fulfill necessary requirements as part of post-market surveillance in documents and records keeping .
• Able to maintain compliance to advertisement regulations and respective labeling requirements in each marketing territory.
• Independently execute Other Authorities Compliances with relevant authorities / government bodies such as Poisons (MOH MY, HSA SG), Flammables & Hazardous Substance (HS) (NEA SG); SIRIM/ IMDA (MY; SG); DVS/ AVS (MY; SG).
• Independently execute yearly RA Audits internally and document findings effectively.
• Support external regulatory agency audits/ Principal audits/ Supplier audits, providing regulatory input to minimize potential for findings of non-compliance.
• Support internal audits of respective subsidiaries and associated companies in South East Asia on Regulatory matters.
• Support Routine Product Compliance Status (MDA, HSA, Other Authorities) Updates into ERP Systems, Verifying Product Compliances, updating product master list, IT batch uploads and logistic uploads for MDA Labeling database.
• Support Routine Updating of Registration master list (Regulatory Database).
• Actively participate in regulatory projects and provide inputs to process improvement.

Requirements

• Proactive, high performance, result oriented and manage projects with ethical integrity.
• Excellent written and Verbal communication skills with the ability to listen, articulate and advocate.
• Possess good communication skills and ability to liaise with authorities, consultants, auditors and foreign manufacturers.
• Scientific knowledge must be able to digest complex data while keeping the big picture through good analytical skills.
• Technical system skills (e.g. MS office applications, databases, efficient online research).
• Good organizational skills, meticulous, planning and presentation skills.
• Demonstrate both creative and critical thinking skills.
• Good in understanding processes/workflows, keen to innovate and improve.