Job Detail



Specialisation: Science & Technology/Laboratory
Education Qualification: Bachelor Degree
Professional Degree
Work Location : Iskandar Puteri, Johor
Salary Range : RM 7,000.00 – 8,000.00
Posted Date : December 05, 2018
Role/Job Description: (to be filled by the proposer)
1) Understanding about Biosimilar development program
2) Knowledge about Biosimilar Regulatory requirements eg; ICH, USFDA, EMA etc.
3) Ability to support and review for analytical and technology transfer activities 
4) Ability to write and review the high quality CMC part of the dossier 
5) Preparation of product registration dossiers in ACTD/ ICH CTD format and any other country specific formats
6) Review the documents from various validation exercise and study protocols required to support product registration
7) Providing the data to various customers and partners after the internal review and maintain registration trackers
8) Understanding the various export market requirements 
9) Preparation of DMF for Drug substances
10) Preparation and submission of site registration application
11) Coordination of external audits/ visits
12) Interacting with various  cross functional teams for monitoring the progress of the project 
13) Creating and maintaining the database of the received documents
14) Preparing the submission related summaries from the study reports and approved documents
15) Maintaining the archival of the various communications/ submission documents
Technical / Functional Skills
1) Experience in regulatory function for Biologicals is preferable
2) Hands on experience on regulated and non-regulated market submissions for biologicals/ biosimilars/ Injectable products
3) Good oral and written communication skills in English
4) Sound knowledge to operate Microsoft Office
Behavioral / Management / Other Skills :
1. Should possess good communication and interpersonal skill
2. Able to interact effectively with the cross functional team in the organization (R&D, Quality and Manufacturing) and outside the organization (agents/customers/ partners)
3. Should be team player
4. Willing to relocate to Johor
Kindly contact Mr Hanafi at 019-7851503 / 07-230 5453 ext 21 email [ ] for further details