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Regulatory Affairs Specialist

Career

Regulatory Affairs Specialist

Your Exciting Role

Conduct research and prepare all necessary documentation required for the application and acquisition of licenses or certifications needed by the company.
Create, propose, and analyze strategies and options that can be pursued to obtain the licenses or certifications needed by the company.
Be responsible for providing and managing the archival and administrative processes of each product or company compliance registration, ensuring that deadlines are met to obtain approval from the government or relevant stakeholders.
Coordinate and facilitate the company's compliance needs to obtain every required approval or certification, including but not limited to establishing communication and maintaining close relationships with registration authorities and related organizations/agencies, and communicating with the relevant authorities to obtain the licenses or certifications needed by the company.
Stay updated on changes in legislation and regulatory guidelines and analyze their impact on the company's business activities, in relation to licensing for human medical devices (CPAKB, CDAKB, IDAK, IPAK, Distribution Permit (AKD and AKL), TKDN), fish drugs (CPOIB, Quality Testing, Distribution Permit), and/or animals.

Ideally, You Would Have

Holds a Bachelor or Master in Pharmacy or other related fields.
Experienced in Regulatory Affairs at a pharmaceutical, medical device, or FMCG company.
Preferably has more than 2 years of experience in licensing for human medical devices (additional value if experienced with fish and/or animal drug regulations) and dealing with relevant government agencies, such as the Ministry of Health.
Able to present information clearly to non-technical teams both verbally and in writing.
Possesses strong knowledge of the human medical device industry. Has good time management and archiving skills, good interpersonal skills, the ability to multitask, and a willingness to learn.
Possesses strong character, high initiative, actively participates in the team, has a high sense of responsibility, and is experienced in communicating with the Government.
Good computer skills, including experience with Google Workspace (Sheets, Slides & Docs) or MS Office (Excel, Word, and PPT).
Has high integrity, is honest, dynamic, highly organized, and has excellent attention to detail.
Proficient in English—both written and spoken.

Regulatory Affairs Specialist

Legal & Regulatory Affairs

Full-Time

Jakarta

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