[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
[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