Regulatory Affairs & Pharmacovigilance Specialist - Malaysia
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- Do you wish to be part of one of the Company’s ‘growth engines and live the future today?
- Do you perform best where change is daily and the unexpected, routine? Do you wish to make a difference?
- The prevalence of diabetes in South-East Asia is growing rapidly and there are increasing expectations to provide effective treatment and care for people suffering with diabetes.
- It is our clear ambition to outperform competition and continue as the undisputed leader in diabetes care across South-East Asia.
About the Department
- Our new RA & PV Specialist will have a key role in the Clinical, Medical, Regulatory Affairs & Quality (CMRQ) Team.
- The team is responsible for driving CMRQ strategies and support effective implementation at the operational level across the business area.
- You will be reporting to the CMRQ Director, with a functional reporting line to the Regulatory Affairs Manager.
- As RA & PV Specialist, you monitor, plan and facilitate company product registrations, renewals, variations and labels .
- You will take country RA and PV responsibility as needed by management. You will monitor and maintain RA and PV KPIs and arrange RA/PV reports to stakeholders and monitor, report and coordinate adverse drug reactions reporting. You are familiar and are a super-user for the various related IT systems.
- As member of the PV Group, you have full country oversight of PV compliance activity including mapping the process and responsibility.
- You will monitor local PV regulations, ensure implementation and compliance of the same as well as coordinate and ensure updated safety data exchange agreements with external business partners. You will play a key role in audit/inspection preparation and learning of experience from other audit/inspection – including ensuring affiliate’s readiness for PV audits and inspections You will also support Quality Assurance compliance as per company guidelines and external requirements.
- As an integral business partner in the diabetes area you are expected to invest significant time and effort in supporting and working alongside affiliate colleagues of all levels across the region.
- You will be a key interface between affiliate, business area, regional and corporate headquarters ensuring full alignment of commercial priorities and strategies.
- We are looking for a person with a University degree in Science or equivalent, with a minimum of 2 years of experience in regulatory affairs and quality.
- Prior working experience covering several countries is considered a plus.
- You have a proven track record in regulatory affairs, pharmacovigilance and quality in the pharmaceutical industry.
- You possess strong MS Office skills and handle stakeholder management in a matrix organisation set-up.
- You are familiar with product and regulatory affairs knowledge within the diabetes therapeutic area and prior experience in the insulin segment will be an added advantage.
- You are open-minded, a fast learner and fluent in both written and spoken English.
- You are willing to travel up to 30% of your working time within the business area and occasionally to the regional and global headquarters overseas.
Working with Us:
- We use our skills, dedication and ambition to help people with diabetes, haemophilia and growth hormones deficiency.
- Our key contribution in discovery and developing innovative biological medicines has made us one of the few companies with the richest new product pipeline in the healthcare industry.