Job expirat
We are an international CRO looking for a Registration Officer in Pharma industry.
This is an entry level position with initial training provided. This highly interesting role encompasses a variety of interesting tasks and responsibilities and therefore provides a great opportunity to develop regulatory affairs skills and knowledge.
Typical work activities include:
• keeping abreast of international legislation, guidelines and customer practices;
• collecting and collating a wide range of information;
• preparing submissions for MRP/DCP and of licence variations and renewals to strict
deadlines in cooperation with PM team;
• monitoring timelines for procedures, licence variations and renewal approvals;
• working with specialist computer software and resources;
• liaising and communication with regulatory authorities and the Clients;
• negotiating with regulatory authorities for marketing authorisation;
• working with a team of RA PMs across EU and in India
The role will be based in Cluj, Romania and will involve knowledge of any EU language and great English skills, as clients are in close cooperation with the Regulatory authorities on these territories.
You need to be a quick learner, self-motivator keen on working on your own. Preferably with pharma background- but this is not essential.
Interviews will be conducted very soon so please contact Anna Szymanska immediately on annas@elc-group.com
Oferim pachet salarial motivant (salariu fix, bonusuri periodice în funcţie de performanţă), aprecierea şi renumeraţia corespunzătoare a muncii bine efectuate.
Momaja Expert este o companie care oferă servicii de regulatory affairs companiilor farmaceutice din Europa. Cu o experienţă de peste 5 ani în domeniu, Momaja Expert oferă servicii pentru realizarea testelor de lizibilitate companiilor din Europa şi recent şi companiilor din România. Scopul testelor de lizibilitate este de a îmbunătăţi şi simplifica informaţia prezentată în prospectul unui medicament astfel încât prospectul să poata fi înţeles de pacienţi, indiferent de gradul de educaţie al acestora.
Mai multe detalii despre profilul companiei pot fi găsite pe adresa:
www.elc-group.com
