Regulatory Staff (Contract), PT Merck Tbk - Jakarta Raya

PT Merck Tbk

PT Merck Tbk. is a leading multinational company in the pharmaceutical and chemical business in Indonesia. Founded in 1970, PT Merck Tbk went public in 1981. The majority of the shares are held by the Merck Group, headquartered in Germany, which is the oldest pharmaceuticals and chemicals company in the world.
In the Chemicals business, Merck markets a whole range of laboratory reagents, pigments and other specialty chemicals. In pharmaceuticals, we manufacture and market well-known pharmaceutical brands such as Neurobion®, Sangobion® and Glucophage®.
To accelerate our growing business, we are looking for a result-driven, dynamic and energetic candidate to fill the vacant position as:

Responsibilities:

 

• Prepare/ Assess existing product documentation (dossier) for medical devices (according to DEPKES/ BPOM/ASEAN requirements);
  
• Prepare/ Assess existing product documentation (dossier) for bio-science products (according to DEPTAN requirements);
  
• Prepare/ Assess existing product documentation (dossier) for imported products and chemicals regulated by the government (according to DEPDAG/ director generals and foreign requirements);
  
• Involving in controlling regulated items (such as Precurcors, B3, B2, etc). Implementing the SOP and submit license monthly report;
  
• Establish and maintain good relationship with external mainly with government authorities, dealers, and precursor users
  
  

Requirements:

• Candidate must possess at least a Bachelor's Degree of Pharmacy/Pharmacology or equivalent.
• At least 1 year(s) of working experience in the related field, preferably have an exposure to Government agency as a Regulatory or License Officer
• Good Communication Skills, tidy and sistematic.
• Fluent in english and also familiar with Ms Excell
• Contract positions available (about 3 months).

If you meet the above requirements, please submit your application, CV, related supporting documents, and a recent photograph, to:

opportunity@merck.co.id

Please put the code "Regulatory Staff" as the email subject