Monday, September 8, 2008

Singapore - Director, Drug Regulatory Affairs Snr

Snr / Director, Drug Regulatory Affairs Sep 08Key Responsibilities

Working very closely with the CEO, you will direct the day-to-day operations of the Regulatory Division. As an expert for the organisation, you will provide guidance in regulatory issues project teams plus direct and review the preparation of regulatory submissions to health authorities. This senior role will act as a primary interface with regulatory clients, providing specific regulatory consultancy & reviewing the preparation of documents, reports or regulatory submissions for particular projects within various project teams.

You will lead a division to ensure that drugs, innovative therapeutics, medical devices and health-related products are reviewed for regulations to meet appropriate standards of safety, quality and efficacy in Singapore. You will also advise on programs for drug administration to safeguard public health and contribute to the development of the biomedical sciences within a robust, scientific and responsive regulatory framework. In addition, you will help ensure that medicines, innovative therapeutics and health-related products meet appropriate standards of safety, quality and efficacy with the view to protect public health and safeguard the interests of the patients and users.

Skills Requirements

You will be a senior regulatory affairs professional, ideally an associate director or director with experience in a Pharmaceutical, Clinical Research, Biotechnology, company or regulatory consultancy, with at least 8 years of relevant experience. You will have at least a Bachelor's Degree, ideally with a Master of Science or PHD, preferably in a life science. You are expected to maintain current knowledge of regulations & regulatory guidelines.

Person Requirements

You are likely to be a very analytical, detailed and accurate person, coupled with ability to handle multiple responsibilities, priorities, tasks and projects simultaneously. You must have strong management & people skills, with the acumen to handle sensitive issues with multiple priorities. A "can do" attitude, together with proactive & far-sighted thinking in the face of complex issues, would be success factors for this role.

Our Invitation

For immediate consideration, we specially invite you to explore this opportunity by emailing us your professional profile. Your interest will be treated in confidence. You may also contact Audrey at Tel: 63379037 for a confidential discussion.

Please be informed that only short-listed candidates will be contacted.