CMC RA Specialist (Contract)

[Summary of Position]

1. Authoring/reviewing CMC modules (Quality part) of CTD dossiers as per the applicable regulation for renewals, new registrations, variations and B2B business. 

2. Co-work with QC/QA and RA for change control management: CMC documents review and guide

clearly to put relevant information.

3. Accountable for ensuring effective CMC dossiers and life cycle management of products, in line with legal / regulatory requirements need.

[Responsibilities]

1. Life cycle management: Authoring/reviewing CMC modules of CTD dossiers as per the applicable regulation for renewals, new registrations, variations and B2B business

2. Regulatory compliance: gap analysis between the current dossiers and current applicable guideline with

cross functional team

3. Co-work with QC/QA and RA for change control management: CMC documents review and guide clearly to put relevant information

4. Co-work with regional CTD Team for preparation of the CMC modules

[Qualifications]

1. Bachelor’s degree is required in chemistry, biology or biochemistry.

2. Good interpersonal and communication skill, fluent in English language (Speaking/Writing/Reading) is advantageous

3. More than 1 year-experience in pharmaceutical company (R&D or Quality, RA experience is preferred)

4. Good knowledge of pharmaceuticals related regulations.

5. Ability to manage multiple assignments simultaneously, work independently and as part of a team.

6. Requires initiative

7. Strategic problem-solving skills

8. Highly motivated with high personal and ethical standards

9. Cross-Functional Collaboration for Common Goal