Regulatory Affairs Officer

Purpose: This position is for registration and other relevant regulatory activities of AC, IC products (medical device and biocide)

Task and responsibility:

1. Update regulation/ internal process of local HA regarding registration activities

- Cooperate with local marketing to get confirmation on registration needs and request required documents for registration

- Assess dispatched documents, and prepare dossiers for submission

- Submission of the registration dossier, follow up and submit supplement dossier if any to get approval

- Request, prepare, submit, and follow up variation dossiers as change management

2. Update regulation/ internal process of local HA regarding registration activities

- Understand clearly all the current regulations regarding product registration including medical devices and biocides, and update and implement new regulations if any

- Understand all internal processes of local HA (IMDA, VIHEMA) regarding evaluation activities of registration. update and adapt timely

- Update and share with the team and relevant department for implementation

- Cross-function support including tender support and collaboration with SCM for the importation of registered products

3. Provide and order required documents as per LSM request for tender

- Coordinate with LSM, and SCM for the importation of registered products, and provide legal or technical documents to them for their process.

4. AW development

- Do artwork development after getting approval for product registration for production

- Do keep informing SCM of the progress of the AW development implementation timeline for placing orders and any changes if any

- Pharmacist or Chemical bachelor, at least 1 years of RA experience (medical device), working in MNC or RA experience of pharmaceutical product is a plus

- Having experience & good knowledge in registration activities

- Working experiences in Pharmaceutical/Medical companies are preferable

- Good relationship with the authorities related to registration task is preferable

- Good knowledge and understanding of concerned legal requirement related to product registration for medicinal, medical devices, supplement and infection control products as well as company operational registration

- Good at English both verbal and written.

- Strong verbal and interpersonal skills

- Customer-service oriented

- Self-motivated, requires little direction

- Careful, honest, high sense of responsibility

- Able to work on multiple priorities simultaneously

- Able to follow directions and pay attention to details and deadlines

- Computer literacy, proficient in Microsoft Office Software