PT Sixmurs Perdana
Regulatory Affairs Officer
- Ensuring compliance with regulation
- Managing to do the whole process of product regsitration, including but not limited to compiling ther required documents, review the documents to check the sufficiency of the content with the local requirement, dossier preparation and submission to the related Health Authority, follow up until the license is approved.
- Ensuring the submission of product registration license or other license(s) meets the timeline provided.
- Monitoring and setting timelines for license renewal and amendment to strict deadlines.
- Consultancy, advocacy and negotiation to the related Government or Authority for any cases related to the regulatory matters.
- Being updated for any new regulation, guidelines and issues that currently happen
- Analyzing complicated information, to give and advice about the case
- Managing the regulatory inspections
- Providing strategic advice to the manager throughout the development of the regulatory
- Bachelor of Pharmacy (Apothecary), Chemical Engineers, Food Technology and other Science related fields.
- 1 year experience in related field
- Hardworker, having a good communication skill, comply to the government and company policy.
- Fluent in English (active)
- Have a good interpersonal and attitude
- Have good analytical thinking and attention to details
- Hard worker, fast learner, discipline, have a good communication skill, creative and innovative.
- Able to work in a team as well as work independently
- Good in handling the stress of tight deadlines
- For replacement at Kelapa Gading North Jakarta
|Lokasi||Kelapa Gading, Jakarta Utara, DKI Jakarta|
|Industri||Bisnis / Konsultasi Manajemen|
|Perusahaan||PT Sixmurs Perdana lihat lowongan|
PT. Sixmurs Perdana was established on June 2009 by Indonesians -who have multinational background- as the professional regulatory consultant for healthcare products in Indonesia.
Further development. As response to the needs of customers, the company was eventually been developed to become full healthcare business consultant, by providing market research service, clinical research and hospital management consulting service and other related services, such as license holding (via PT Mursmedic, the sister company of Sixmurs), document translation (with special expertise in medical and scientific paper) and business establishment service. We also regularly provide training on regulatory competency development and regulatory updates in Jakarta and Singapore.
Expansion to other region. On 2011, we extended our regulatory services, which covers regulatory advice/ intelligence and product registration to another 5 ASEAN countries (Malaysia, Philippines, Thailand, Singapore and Viet Nam). Limited services to other region (such as Australia and New Zealand, Hong Kong, China, and India) are also available on request.