Major accountabilities:

• Drug Regulatory Expertise: Utilize scientific information and a broad understand of biomedical/pharmaceutical sciences and working proactively to optimize drug product registration. Recognizes scientific issues as relevant to project, creates awareness and communicates issues to the team.
• Regulatory Communication and Negotiation: Proactively communicating and effectively negotiating internally and externally, understands routine/basic health authority requirements and how the health authorities operates. Communicates with health authorities and report on progress to superior. Effectively communicates and negotiates with peers on regulatory strategies and operational issues.
• Operational Excellence: Uses appropriate databases to complete job activities and archives.
• Regulatory Science: Understands the importance and relative priority of submissions to health authorities. Applies laws, regulation and guidelines to ensure compliance.
• Commercial Awareness: Recognizes basic business, commercial and economic terms. Understands the commercial impact of delays in product introduction and/or changes to the product label.
• Science and Technology for DRA: Understands scientific terminology and general drug development, able to follow scientific presentations in order to complete job activities. Understands scientific discussions and can meaningfully report content of discussion.

Requirements: 

• 1-2 years experience in regulatory affairs
• Degree/ Diploma from a health care or scientific discipline
• Relevant experience working as Medical, Safety or Administrative support acceptable.
• English fluent in speaking and writing.
• Higher position will be offer based on experience.

(All information received will be kept in strict confidence and only for recruitment purpose. Applicants who are not invited for interview within 6 weeks may consider their applications unsuccessful.)