Job Description

The local RA manager is assigned to multiple products and could support other projects led in RA department. 

- Ensure timely registration of new products and maintenance of approved products

- Local coordination and execution of regulatory submission in compliance with internal standards and local regulatory requirements

- Develop and execute registration strategies

- Lead the labelling & promotional material review & approval process

- Monitor and analyses changes in relevant local regulations, guidelines and regulatory environments

- Comply with all local regulations while executing the assigned roles and responsibilities as defined in the local regulations, guidelines etc.

Qualifications

- More than 5 years experiences in local RA fields

- Depth knowledge of local legislation and regulations relating to medicinal products. 

- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.

- Depth understanding of the registration procedures and challenges in local for NDA and all activities for lifecycle managements

- Various knowledges and experiences in local regulatory environment for development of new products and registration of them

- Good negotiation skills & communication skills

Additional Information

- Having experiences on medical devices is preferable. 

- A pharmacist is preferable, but not limited.