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Regulatory Affairs & Pharmacovigilance Specialist Kuala Lumpur Malaysia,  

Posted on : 10 April 2017

Project Description

Requisition ID 46353BR Title Regulatory Affairs & Pharmacovigilance Specialist, South-East Asia Job Category Regulatory Affairs Job Description 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. Business Area South-East Asia (BASEA) office based in Kuala Lumpur, Malaysia is one of Region Africa, Asia, Middle East & Oceania s (AMMEO) five business areas - dynamic with big growth opportunities and looking for a Regulatory Affairs & Pharmacovigilance (RA & PV) Specialist. The countries represented in BASEA include Bangladesh, Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam, Sri Lanka, Brunei, Cambodia, Laos, Maldives, Myanmar and Timor Leste.  About the DepartmentOur new RA & PV Specialist will have a key role in the BASEA 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 BASEA CMRQ Director, with a functional reporting line to the BASEA Regulatory Affairs Manager.  The position is located in Kuala Lumpur, Malaysia.The PositionAs RA & PV Specialist, you monitor, plan and facilitate company product registrations, renewals, variations and labels for BASEA  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 BASEA 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 Novo Nordisk 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.   QualificationsWe 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 at Novo NordiskAt Novo Nordisk, we strive for excellence. You share the same passion and commitment as our employees in our journey to make a difference to patients  lives. In exchange, we offer you the chance of a lifetime to work with extraordinary talent and benefit from unmatched opportunities for professional and personal development. ContactFor further information, Srinivasa Rao, Senior Regulatory Affairs Manager BASEA can be contacted at Kindly send your CV and motivational letter online (click on Apply and follow the instructions). Internal candidates are kindly requested to copy/inform their line Manager.  Deadline19th April 2017 State/Provinces Kuala Lumpur Position Location Kuala Lumpur Full Time or Part Time Full Time


Malaysia Kuala Lumpur

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