- Responsible for the recruitment of staff, establishment of organization structure and the management of the Regulatory and Clinical Affairs team in Indonesia.
- Oversee the strategy implementation and operation for directing development of product registration, submission, progress reports, supplements, amendments, or periodic experience reports.
- Interact with regulatory agency to expedite approval of pending registration. Serve as regulatory liaison throughout product lifecycle.
- Participate in product planning, development and implementation; regulatory and clinical strategy; and risk management.
- Serve as regulatory representative to marketing, research teams and regulatory agencies.
- Advise development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations.
Only relevant candidates will be contacted. We are looking for someone who has the willingness to join a company at early expansion, enjoy independence and thrive in building from the ground up.
- Bachelor's degree in Pharmacy, Medicine or bio-medical related areas.
- Preferably 5 years of working experiences as Reg and Clinical Affairs in Medical Device, IVD or pharmaceutical industry.
- If you have experience with IVD, experience on chemiluminescent reagent and instrument registration is a plus point.
- Preferred experience on overseas technical transfer for medical products.
- Some knowledge or experience in clinical trial coordination.
- Familiar with regulatory and clinical research regulations and process, with good knowledge on IVD related quality systems such as ISO13485, GMP etc. would be a plus.
SEA Presence, work closely with Regional Team in the expansion for Indonesia
Michael Page