Your primary duty is to manage all related Clinical, Medical, Regulatory and Pharmacovigilance aspects of business including a specific focus on Research and Development (R&D) pipelines within Southeast Asia (SEA). This position will report to the Corporate Vice President, and it will be based in Singapore. You will have 6 direct reports in SEA and functional reporting of affiliate - Clinical Medical Regulatory (CMR) Heads.
- The main scope of accountabilities includes but is not limited to:Head Clinical Medical Regulatory (CMR) strategy (short, mid, and long term) and performance management in alignment within SEA. Drive for Best practice and operational excellence. Communication and interaction with both internal and external stakeholders.
- Clinical operations - Oversee Clinical activities in SEA and endorsement of local trials as well as explore new opportunities/countries.
- Medical Affairs – take care of therapeutic areas in Business Area, SEA as well as aid and drive medical projects.
- Regulatory Affairs - Strategize, initiate, plan and coordinate with necessary departments including corporate regulatory affairs, trademark for regulatory submission, approval, and maintenance of licenses. Ensure the units are in compliance with Regulatory and Pharmacovigilance requirements.
- Pharmacovigilance – Ensure company safety standards are followed. To ensure the units within SEA operates in compliance with Regulatory and Pharmacovigilance requirements and ensure discussions with General Manager (GMs)/ Multiple Country Manager (CMs) with SEA to allocate resources and provide means that allow employees to fulfil their duty Work according to the company values, the business ethics, and internal laws.
Qualifications
- Minimum of 12 years experience with 8 years of people management in senior roles in the pharmaceutical industry. Experience in randomized controlled trials (RCTs), real-world evidence (RWE) - Observational studies, Prospective studies.
- Medical Doctor with MD is mandatory.
- Global R&D experience is required in conducting multinational clinical trials. Global knowledge of Medical Affairs and requirements for Regional Medical Affairs.
- Experience in engaging with Regulatory bodies and drug safety. Experience in translating clinical evidence into strategies for successful product development and launch preparation.
- Have excellent managerial skills, strong matrix and influencing skills.
