Regulatory Affairs Manager

Responsibilities:

• Ensure drug registration activities are proceeded in accordance with relevant local, PRC and overseas regulations
• Provide overall regulatory guidance towards execution, review & approve all packaging materials and marketing tools to comply with HK, PRC & oversea regulation
• Develop the strategy plan to obtain the product approval within target timeframe;
  Collaborate with internal & external departments to facilitate product development and registration.
• Monitor and communicate within the company for the current and proposed changes on drug registration dossiers to ensure all the operations within company relating to product registration comply with the regulatory requirements and business needs;
• Supervise and monitor all supporting activities relating to drug regulatory requirements are proceeded according to schedule.
• Coordinate new product development projects to ensure alignment with business goals, target product approval timeframe and GMP requirements.
• Occasional to work at Yuen Long Factory is required

Requirements:

• Bachelor Degree or above in health-related science, Medicine, Pharmacy, Biological Science or other Medical related field
• At least 5 years solid experience in regulatory affairs or pharmaceutical/FMCG industry; department of GMP certified pharmaceutical is highly preferred
• Able to work independently, adaptability and attention to detail with a strong orientation, well-organized and responsible
• Excellent communication and presentation skills
• Good command in spoken and written Chinese and English

Interested parties, please send full resume with present and expected salary to the HR Department by email to [via CTgoodjobs  ]

(Information provided will be treated in strict confidence and will only be used for recruitment-related purposes.)