Regulatory Affairs Specialist

Job DescriptionPlan, prepare and submit product registration application (new, renewal & variation) to competent authorities in Malaysia and other countries where the company is exporting to.Follow up on registration applications with relevant authorities and business partners.Gathering, collating and evaluating a wide range of information via references and various media inclusive the internet.Collecting, coordinate, evaluating and compile data and documents in a variety of format.Liaising and negotiating with government agencies and business partners.Keeping abreast of local and international legislation, guidelines and practices.Providing advice to other departments as appropriate. Job RequirementSelf-discipline and sense of duty, strictly adhere to company policies, administrative procedures and code of conduct.Degree in pharmacy, biomedical sciences, biochemistry, biotechnology or relevant science field.Good interpersonal and computer skills.Self-motivated with strong initiative and able to work independently in a challenging environment.Able to prioritise and organise workload, adapting to fit the changing needs of the business.Able to converse in Bahasa Malaysia and English.Strong team-working skills and able to communicate clearly and effectively, verbally and in writing.Experience in product registration/ regulatory affairs and knowledge in pharmaceuticals (New Drug Product) would be an advantage