Regulatory Affairs Specialist/Manager

HAYS Poland jest firmą doradztwa personalnego, należącą do międzynarodowej grupy HAYS plc, notowanej na giełdzie w Londynie i największej firmy rekrutacyjnej w Wielkiej Brytanii.

Grupa posiada ponad 390 biur w 27 krajach na całym świecie, w których łącznie pracuje 8 300 specjalistów. Jest liderem w Europie Środkowej i Wschodniej, Azji, Ameryce Południowej, Australii, Nowej Zelandii, Chinach, Japonii, Hong Kongu i Kanadzie.

For our Client, international company, the expert in the field of medical and hygiene devices, well known in the world for the very good quality, we are currently looking for Regulatory Affairs Manager.
The person will be responsible for creation and development of RA Department for the Eastern Europe Cluster.
We are looking for self-motivated person with independent working style as will have the comprehensive responsibility of entire portfolio of registrations in the Eastern European countries.
The portfolio consists of biocides, cosmetics, medical devices and medicinal products.
The person will analyse current set up of product registrations and the relationship between Marketing Authorization Holder and Distributor and will propose alternate solutions for the entire registration set-up within company concerning Eastern European countries development of an implementable registration strategy considering the requirements of the different stakeholders such as sale, marketing, headquarter, manufacturer, legal framework, etc.

The responsibility of that person will be supervision, support, and proactive participation in the registration processes in close collaboration with headquarter regulatory affairs department and the domestic companies of the Cluster as well as external consultants, development of this area including an international network of consultants and experts.
Processing the type I and type II modifications of the medicinal products,such as: changing the suppliers of the active substances, changing the packaging types, changing the microbiological effectiveness, changes of the safety of the medical products, expiry of permissions, changes of the formulations of the analytical methods, validation methods, address data changes.

Regulatory Affairs Manager will be cooperating with the headquarter RA Department in preparing the reports and cooperating with the Marketing Department when preparing new printed marketing materials: labels, leaflets etc.
This is the person who will be working on the final version of labels and leaflets in cooperation with the unit responsible.

In the rest of the scope of duties of that person will be: processing changes in permissions for the biocidal products’ sales, the transfer of the unit responsible for the biocidal products, placing the necessary documentation to the URPL within the required timeframes; constant monitoring of the processes in progress, adding cosmetic products to the CPNP database, processing the applications for the medicinal products in the URPL, updating the applications, participation in internal and external audits – both as the audited unit as well as an auditor.

Regulatory Affairs Manager will be reporting to Quality Manager of the company.

Prosimy o dopisanie następującej klauzuli „Wyrażam zgodę na przetwarzanie moich danych osobowych zawartych w ofercie dla potrzeb procesu rekrutacji zgodnie z Ustawą o ochronie danych osobowych z dnia 29.08.1997r., Dz. U. Nr 101, poz. 926 ze zm.” Numer w rejestrze agencji zatrudnienia: 361 hays.pl