phc regulatory assistant | budapest

megjelenés dátuma
kapcsolat
szilvia kiss, randstad hungary
állás típusa
határozatlan idejű
jelentkezem

az állás részletei

megjelenés dátuma
elhelyezkedés
budapest
álláskategória
asszisztens / recepció
állás típusa
határozatlan idejű
referenciaszám
156153 / 24114
kapcsolat
szilvia kiss, randstad hungary
jelentkezem
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Cégleírás / Organisation/Department

We are looking for a PHC Regulatory Assistant for our multinational partner.

Pozíció leírása / Job description

- To ensure compliance of the product portfolio to applicable regulations, guidelines and company standards.
- Plan and coordinate the preparation & submission of registration and compliance dossiers. Follow and achieve registrations for the medicinal product portfolio according to plan. This includes:
- Defining the requirements for local submission of registration dossiers
- Defining the requirements for products which do not required submission
- To update and maintain dossiers post registration. This will include the submission of variation documents.
- To ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate systems in line with applicable internal company standards and updating regulatory data records (regulatory databases).
- To advise organization of potential regulatory risks in normal day to day activities and recommend compliant actions.
- To review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements on local level.


Elvárások / Requirements

- A minimum a Master’s degree in health-related science, life-science; Pharmacy or Medical degree.
- Excellent English and Hungarian communication skills (both oral and written).
- Ability to understand and apply European and local requirements.
- Ability to work effectively in multidisciplinary and multicultural teams.
- Open minded / can to attitude
- Minimum 1-3 years Regulatory experience (product maintenance, not clinical trials). Experience in medicinal product registration is a must, other product categories is advantage.
- Experience in working across a wide range of regulatory systems and databases



Amit kínálunk / Offer

- Fixed term job for 12 month
- Attractive compensation and benefit package
- Individual training plan
- Challenging job with meaningful responsibility from 1st day at work
- Multinational and diverse work environment

Kapcsolattartó / Applications

Szilvia Kiss