Regulatory Affairs Manager
Consultant Kevin Setiawan
Date posted 07 February 2019 2019-02-072019-04-08 pharmaceuticals Jakarta ID IDR 30000000 50000000 50000000 MONTH Robert Walters https://www.robertwalters.co.id
An exciting Regulatory Affairs Manager job has just become available at a leading Medical Devices company based in Jakarta. This role will report directly to the Regulatory Affairs Senior Director.
About the Regulatory Affairs Manager Role:
As a Regulatory Affairs Manager, this position will be responsible for and oversee activities related to company compliance with relevant regulatory requirements in Indonesia.
- Oversee and manage product registration of company products imported in Indonesia
- Oversee regulatory compliance activities for Ministry of Health, BPOM, including supporting MDO processes, application of relevant permit for RDC activities
- Responsible for execution, regulatory reporting and closure of any regulatory actions on any company product
- Responsible for communication with local Business and Management associates or country's health agencies for registration submissions and other regulatory activities
- Responsible for updating the Director, Regulatory Affairs SEA on any regulatory changes in Indonesia that may have major impact on company Businesses
- Responsible for providing regulatory input, review, etc. for projects, product launches, promotional materials
- Responsible for leading the Indonesia Regulatory Affairs team to meet strategic direction / targets
To succeed in this role, you will need to have a minimum of 10 years work experience in regulatory affairs or quality assurance systems capacity, preferably in the healthcare industry .
- Bachelor’s Degree in science/Biomedical/Pharmacy or equivalent
- Knowledge of US FDA QSR, ISO 13485, MDD, IVDD and relevant countries’ regulatory requirements
If you are driven, determined, and want to take further step in your career, this is the role for you. Attractive remuneration package as well as excellent career progression opportunities await the right person.
Apply today or call me to discuss this new job opportunity.