- Candidate must possess at least a Bachelor's Degree, Pharmacy/Pharmacology or equivalent from the reputable university with GPA min 3,00
- At least 2 year(s) of working experience in Internatioanl Regulatory Affairs (for Export)
- Age : 25-30 years old
- Excellent communication skills, Fluent in English both oral and writen
- Responsible to generate regulatory strategies to support business strategies and market access
- Applicants must be willing to work in Cipete Raya,Jakarta Selatan.
- Preferably Supervisor / Coordinators specializing in Healthcare - Pharmacy or equivalent.
- Full-Time position(s) available.
- Ensuring that a company's products comply with the regulations of the MHRA
- Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to; collecting, collating and evaluating scientific data that has been researched by colleagues
- Developing and writing clear arguments and explanations for new product licences and licence renewals
- Preparing submissions of licence variations and renewals to strict deadlines
- Monitoring the development process related to the product under the exported product pipeline
- Prepare the anual budget for regulatory department
- Monitoring and setting timelines for licence variations and renewal approvals
- Planning and developing product trials and interpreting trial data
- Advising scientists and manufacturers on regulatory requirements
- Negotiating with regulatory authorities for marketing authorisation
- Maintains a profesional relationship with Health Authorities and players of similar insdustry
- Act as project management officer to manage the compliance of the existing product with the approval from BPOM
- Handle quality assurance compliance for overseas such as complaint, recall, return, inspection.