PT. Merhati Keluarga Medika is a healthcare company that focuses in innovative pharmaceutical and medical device products. We are now seeking a _**Regulatory Affairs Officer & PJT **_as the team continues to grow and develop into its next phase.**I. Qualifications & Requirements**- At least 2 (two) years of relevant experience in regulatory affairs in a pharmaceutical company, handling medical devices, OTC, ethical and aesthetics- A minimum qualification of a Bachelor's Degree in Pharmacy or Chemistry from a reputable university and a license as PJT that can be used by the company- Great analytical skills and an eye for detail (accuracy) without sacrificing timeliness (must be on time)- Must be able to speak English fluently, both written and verbal, as you will deal with international parties- Must have experience in dealing with BPOM and in preparing documents for registration purposes- Must be able to work under pressure under tight deadlines- Must possess a strong negotiation, organizational and documentation skill with a systematic way of thinking- Must be self-motivated (strong-willed) with a high discipline, even under minimum supervision**II. Role & Responsibilities**- Prepare, arrange and organize official and administrative documentations/dossiers needed for the registration of medical devices, OTC, ethical and aesthetics products, etc- Liaise and coordinate with external parties including principals, BPOM or other National Regulatory Bodies, and other parties involved if needed to ensure smooth registration processes- Develop and submit regular regulatory and compliance reports, both internally and to external stakeholders, which can include government agencies- Maintaining regulatory compliance of our products according Indonesian or Respective Country Regulation**Salary**: Up to Rp6,000,000 per monthApplication Question(s):- Apakah Anda memiliki Sertifikat PJT yang dapat digunakan perusahaan? (Kami hanya akan merekrut kandidat yang memiliki Sertifikat PJT yang siap digunakan)Ability to Commute:- Jakarta (required)Ability to Relocate:- Jakarta: Relocate before starting work (required)
