Regulatory Affairs
New Product Registration
Review and ensure registration documents received from relevant stakeholders are accordance to current registration requirements.
compile, prepare and submit new registration application
Consult and liaise with respective unit, department, manufacturer and/or principal should additional information required for preparation of product dossiers and during evaluation of product registration, as and when necessary
Follow-through and monitor the registration process for all new products registration submission, as well as all other applications with the regulatory authority and to tackle any queries or problems arise, as and when necessary
Amendments to particulars of a registered product
Variation (inclusive Change of Product Registration Holder (COH) and Change of Manufacturing Site (COS)) etc.
Notify regulatory authority on any changes or amendments of registered products progressively and timely.
Review and ensure variation documents received from relevant stakeholders are accordance to current variation requirements.
Compile, prepare and submit variation application.
Consult and liaise with other unit, department and manufacturer should additional information require for variation submission and during variation evaluation, as and when necessary.
Follow-through and monitor the variation evaluation and approval of products submitted to regulatory authority and to tackle any queries or problems arise as and when necessary.
Maintenance of Product Registration / Renewal of Product Registration
Ensure product that is due for registration renewal comply with the current renewal / regulatory requirement (e.g., Bioequivalence study, Zone IVB stability study, API Information (Drug Master File, CEP or Part II S) and etc.) prior to renewal application.
Ensure product renewal is performed on time / within the stipulated timeline.
Surveillance (Internal and Post-Market)
Check all artwork of existing registered products and to ensure all information in the artwork are as per registered information and comply with the registration requirement.
Co-ordinate, verify and ensure that the documents in the product file (technical specification, certificate of analysis, batch manufacturing record, packaging material etc.) is up to-date.
Product Registration File and Product List
Maintain and keep Product Registration Files for all product up to-date by ensuring all relevant documents (e.g., correspondence remarks and communications from and to regulatory authority, quality data such as stability studies, batch manufacturing records etc.) are filed accordingly for each product.
Update Product List related to respective manufacturer/principal assigned.
Prepare report on the registration status and update relevant stakeholders (manufacturer/principal, relevant divisions or departments) accordingly.
Product Complaint
Assist in the set-up of product complaint management system and manage operation of the system within the organization.
Upon received the product complaint from regulatory authorities or related entity for tender product (e.g., logistics and distribution concession entity i.e.,): -
To acknowledge receipt of complaint to regulatory authorities or related entity
To notify respective manufacturer /principal/supply chain management team for investigation accordingly
Review, prepare and submit the investigation report upon received from manufacturer / principal
Regulatory Licenses
Maintenance of all regulatory licenses related to respective manufacturer and / or principals assigned to enable the company to operate uninterruptedly.
Regulatory Supports to company’s client
Assist in any regulatory advisory work with clients.
Regulatory Updates
Keep abreast on current registration requirements and update plants or relevant divisions or departments accordingly.
Administrative
Support administrative matters of the pertaining to the department activities.
Others
Industry Involvement
Active in industry engagements namely but not limited to MOPI
Undertake any other duties as directed by the Immediate Supervisor and Management as and when required.
