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Fresenius Medical Care Malaysia Sdn Bhd

Fresenius Medical Care is the world’s leading integrated provider of services and products for individuals with kidney failure or End Stage Renal Disease (ESRD), treating an estimated 200,000 patients around the globe. It is also the leader in the provision of dialysis products, with an established network of 2,600 dialysis clinics. We are an organisation that considers further training of employees as a pre-requisite to constantly nurture the innovative power and ultimately investment in the future of the company. To support our continuous growth, we are seeking a top-caliber professional to join our team for a challenging and rewarding career.

Regulatory Affairs Pharmacist
(Selangor - Petaling Jaya)

Responsibilities:

- Ensure full regulatory compliance to all local and international regulations, codes and standards and including pharmacovigilance. (within Malaysia)
- Develop registration strategies, implement regulatory plans and co-ordinate multiple projects & activities in accordance with strategic company objectives.
- Review, analyze and co-ordinate data for new product submissions, line extensions, variations to marketed products.
- Review and approve product information, consumer medicine information, labels and other documentation as required for regulatory compliance.
- Maintain the registration of marketed products .
- Provide regulatory input and support for marketing plans, product launches and other cross-functional activities.
- Represent company at government and industry association meetings and disseminate important information to staff.
- Ensure proper record of product complaint.

Requirements:

- Degree in Pharmacy and registered with the Pharmacy Board Malaysia
- Preferably with some experience in regulatory work
- Self discipline, result driven and able to work independently
- Good command of the English Language and Bahasa Malaysia
- Strong communication and interpersonal skill
- Possess a valid driving licence and own a car
- Fresh graduates are also encouraged to apply

An attractive compensation and benefits package will be given to the selected qualified and experienced candidates. This is a challenging and growing area, as such opportunities for advancement are excellent for those who are willing to learn and excel in their performance. Interested applicants are invited to write/fax their applications with a detailed resume, stating current and expected salaries and contact telephone number together with a recent photograph (n.r) to the following address:
The Human Resource Dept
Fresenius Medical Care Malaysia Sdn Bhd
Second Floor, Axis Technology Centre,
Lot 13 Jalan 51A/225,
46100 Petaling Jaya Selangor
Fax No : 03-7957 1272
E mail : yasmin.jamal@fmc-asia.com