- Liaise with the local Health Authority on matters pertaining to regulatory activities, licenses and permits for new and existing products.
- Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations & processes.
- Review technical dossier of new products and prepare additional documents where necessary.
- In-charge with the timely approval and renewal of product licences, company licenses, pre- and post-approval variations, permits and other applications.
- Provide appropriate solutions for compliance issues.
- Review and approve advertising and promotional items to ensure regulatory compliance.
- Build and maintain relationships with key regulatory officials to influence regulators to achieve positive outcomes for product approvals or industry advantages.
- Keep updated with local Health Authority regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
- Maintain a current awareness of the regulatory requirements for the marketing of medicinal products in Malaysia and general legislation and guidelines.
- Degree qualification in life science related fields.
- Minimum 3 years’ experience in Regulatory Affairs, particularly in drug or medical device. Experienced in registering cosmetic, food supplement or chinese medicine will be added advantage.
- Ability to maintain confidentiality of sensitive areas.
- Ability to work independently, good communication and interpersonal skills.
- Excellent verbal and written communication skills in English & Malay.
- Territory: Singapore & Malaysia