Post Date:
Thursday, February 1, 2018
Reference Number:
PP6243
Client Description:
Our client is a pharmaceutical leader, they are currently seeking a Regulatory Affairs Manager.
Responsibilities:
- Provide supervisory to Regulatory Affairs team by ensuring that appropriate systems, competencies and values are implemented
- Actively participate, analyze and follow-up on relevant RA issues
- Establish ongoing liaison with key opinion leaders, government officials and ensure that significant developments in the field are identified and monitored
- Ensure effective team communication throughout Regulatory Team through the application of suitable reporting systems, structures and the identification and provision of appropriate training. This training would include Pharmacovigilance (PV) awareness and complaint handling (related to adverse events and related matters)
- Ensure that RA Team provides a value-added function to business development and marketing
- To have overall responsibility for ensuring that all regulatory requirements are addressed, including all adverse events are dealt with in accordance with in accordance with company SOPs and international standard
Requirements:
- University graduate major in Science or medical related discipline
- Min. 6 years regulatory affairs experience in pharmaceutical industry with at least 2 years managerial experience
- Good working knowledge and experience on local drug regulatory requirements
- GMP knowledge is preferred but not essential
- Strong interpersonal and communication skills
- Detail-oriented and cross-functional team player
- Proficiency in written and spoken English & Chinese including Mandarin
- Candidate with less experience will be considered as Assistant Manager
Salary:
Negotiable
Industry:
Function:
