Job Description
OBJECTIVES:
To ensure to comply with regulation related activities which govern all aspects of drugs, Quality, Commercial, Manufacturing and Distribution of drugs etc. in both proactive and reactive manner.
To ensure that overall quality management system (QMS) of Takeda Indonesia complies with Takeda QMS requirements as well as local and international requirements.
To ensure that QA activities comply with the prevailing regulation and Takeda standard.
ACTIVITIES & RESPONSIBILITIES:
REGULATORY AFFAIRS
- To ensure that a company's products comply with the national regulations
- To keep up to date with national and international legislation, guidelines and customer practices
- To prepare submissions application of drug registrations, lincense variations and renewals to strict deadlines
- To monitor and set timelines for license variations and renewal approvals
- To advise Global RA and manufacturers on regulatory requirements
- To provide strategic advice to senior management throughout the update of new regulation
- To support regulatory inspections (if necessary)
- Set up, implement and monitor the local Quality Management System (QMS), which must comply with Takeda QMS, other relevant Takeda requirements, applicable international and prevailing national legislation.
- Assure that changes in overlying QMS requirements are appropriately implemented.
- Establish a system to control the Local Standard Operating Procedure (L-SOPs) (i.e. a system for creating, distributing and implementing local procedure as well as monitoring compliances with these), ensuring that the required L-SOPs in Takeda Indonesia are issued according to the Global SOPs and other prevailing national and international legislation and guidelines.
- Minimun bachelor degree from pharmacy faculty
- Minimum - 5 years experience in regulatory and or QA/QMS field
- Have experience in handling product registration
- Have a good network with health authority (BPOM, Kemkes)
- Good command of English
Jakarta, Indonesia
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Takeda