Our client is a fast-growing & reputable pharmaceutical principal with active expansion in Hong Kong in recent years. To cope with their business need, they are inviting high-caliber talents in joining their team as Regulatory and Medical Affairs Specialist.
In this position, you are responsible for the management of the company’s compliance in accordance with relevant regulations and in line with the strategic objectives of the company.
You will provide support for all regulatory activities (such as new product registration, renewals, change variations/notifications) in accordance with Company’s compliance and relevant regulations governing pharmaceutical product registration.
You will work closely with the regional RMA team to ensure regional strategies can effectively implement in the local aspect.
Some Highlights of the role:
Regulatory Affairs Role:
- Responsible to support business strategic launch activities towards Company’s compliance according to Health Products & Therapeutic Products Act in Hong Kong.
- Complete regulatory submissions, including but not limited to new product applications, clinical trial applications, change variation/notification, special authorization routes for new & currently registered products portfolio in Hong Kong.
- Manage submissions requirements through the regulatory management database (RMD).
- Review the promotional material, coordinate the approval process within the organization in order to comply with the laws for medical device sales & advertisement promotion guidance.
Medical Affairs Role
- Cultivating and maintaining a professional 2-way peer-to-peer relationship with local KOLs and fostering mutually productive partnerships with KOLs in the areas of medical education and clinical/scientific research.
- Developing KOL advocacy to drive effective communications and key medical education initiatives in the assigned therapeutic area.
- Able to understand, interpret, communicate complex scientific data and information effectively to KOLs and deliver medical presentations to diverse audiences effectively, including physicians, pharmacists, nurses, and the commercial team.
- Collecting and disseminating actionable key insights and competitive intelligence from multiple sources and maintaining cross-functional collaboration with internal teams: Marketing, Sales, Regulatory, Legal, etc.
- Bachelor’s degree in Pharmacy or related discipline, RPh is highly preferred;
- Minimum 2 year’s relevant experience in regulatory and/or medical affairs area, ideally gained from a sizable pharmaceutical company;
- Knowledge of Regulatory Submission for Pharmaceuticals.
- Understanding Regulations, Acts, and Guidelines for Registration, GMP, GDP, Pharmacovigilance.
- High Attention to detail, accuracy essential and diligent personality;
- Good communication & interpersonal skills and always be a good team player;
- Good command of both written and spoken English.
If you feel that this is the place where you belong and start your career with a ton of new opportunities, please don’t hesitate to apply for the job position.