Pošalji prijatelju

Regulatory Affairs Specialist (m/f)


Rok prijave:

  • Hill International

Our client is an established and long-standing pharmaceutical company with long experience and a strong presence on the market. They have over 1500 employees with subsidiaries and representative offices all over the world. A company with a strong focus on growth and improvement, around 3 percent of total revenue yearly is invested in research and development. With a positive working environment where good work is recognized and rewarded, they base their history of success on professionalism and commitment to its employees. In order to strengthen their position on the market, adapt and improve their business model and increase their competitiveness, they are looking for a:

Regulatory Affairs Specialist (m/f)

On this position, you will be responsible for planning and managing medicine products/medical devices/food supplements registration processes according to the company business plan as well as planning and managing local regulatory submissions in compliance with local regulatory requirements. You will communicate with Regulatory Authorities and contractors regarding registration of medicine products and food supplements. You will track a product life cycle, prepare normative documents, patient leaflets, contracts/agreements associated with registration process of medicine products/medical devices/food supplements and actively update the management regarding upcoming changes in regulatory environments. Also you will act as pharmacovigilance backup in collaboration with the HQ PV department and local Pharmacovigilance Specialist.

We are looking for someone with minimum 3 years’ experience in Regulatory Affairs able to grasp new concepts and willing to try new approaches. Experience in Pharmacovigilance will be considered an advantage as well as other relevant areas such as research, Quality Control, QA or manufacturing within the pharmaceutical industry. An active knowledge of English and computer skills are also required, along with high product knowledge and excellent communication and presentation skills.

Our client offers you an innovative and supportive environment where you can achieve your full potential and grow within a well-known company. Continuous regulatory and pharmacovigilance education and training will be provided for professional development along with a competitive salary.

If you are interested in a challenging but rewarding position, please send your CV and application to:

HILL International - Zagreb d.o.o. za posredovanje pri zapošljavanju
Draškovićeva 40, 10 000 Zagreb, tel: 01/481 06 60

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