Regulatory Affairs - Senior Specialist

Biomed Global

Fresher

Not Disclosed

Malaysia, Selangor

Posted 49 minutes ago
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Job Description

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.