Job expirat
MSD is a global healthcare leader working to address unmet health needs.
MSD is inspired by the difference it can make in the lives of people around the world through the innovative medicines, vaccines, and consumer health and animal products they discover and produce. MSD works with customers in 140 countries to deliver broad-based healthcare solutions and aspire to be the best healthcare company in the world and to make MSD the pharmaceutical company of choice by recruiting, training and managing the best people.
Position Overview - Basic Functions & Responsibility:
Under supervision of the Regulatory Affairs Manager, the Regulatory Affairs Coordinator:
o Is responsible for providing regulatory administrative support and coordination for the department, with maintenance of tracking systems and databases, translations, preparing submissions, renewals, maintenance of local files as well as translations and artwork management;
o Contributes in other regulatory tasks, as required.
Major Activities include:
Administrative office routines:
• Assists in compilation and submission of regulatory documents to the local regulatory authorities and – as applicable - to the European Medicines Agency (EMA) related to new applications, variations, renewals, managing invoicing etc.
Editing and labeling:
• In connection with submission of MA applications, variations, renewals etc. assists in preparation, translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and performs quality assurance including linguistic check of these documents.
Art-work development:
• Ensures that artwork including all package components (leaflets, labels, outer cartons etc.), is developed in a timely and correct manner and according to relevant Artwork Management procedures.
• The Regulatory Affairs Coordinator reads packaging components and is responsible for maintaining an updated file on packaging components, as applicable.
Skills Required:
• Must have a post-secondary education in scientific science or equivalent and must demonstrate basic medical and scientific understanding and knowledge.
• Should demonstrate basic skills and knowledge of local and EU medicines legislation and regulatory procedures and must have the ability to plan and prioritize regulatory tasks to meet MSD and local objectives.
• Must demonstrate good interpersonal skills, capability of problem resolution and the ability to work in a team.
• Commitment, dedication to quality and the ability to handle multiple priorities simultaneously is a key condition.
• Proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database applications, and internet is a key condition.
• Previous experience in a Registration Department and in dealing with most aspects of registration would represent an advantage.
• A rigorous appreciation of the interactions and relationships of the dept. with other groups internally is expected.
What we offer:
• The opportunity to join a young and vibrant team where you can bring your contribution and your opinion will be valued.
• A positive and encouraging work environment.
• A competitive package.
ADECCO RESURSE UMANE SRL
Romania, Bucuresti, sector 1, str. Dr. Iacob Felix Nr. 28, Etaj 4
Nr. ORCB J40/12364/2003, CUI RO15739037
Capital social subscris si varsat: 392.440 Lei
Nr. autorizatie Agent de Munca Temporara: 17/2005
Autorizatie seria nr. B/ 0000008/25.10.2005
Nr. Operator Date Personale: 15866
Tel: 00 40 21 300 35 46, Fax: 00 40 21 300 35 54
E-mail: office@adecco.ro, Web: www.adecco.ro
ADECCO ROMANIA SRL
Romania, Bucuresti, sector 1, str. Dr. Iacob Felix Nr. 28, Etaj 3
Nr. ORCB J40/4467/2000, CUI RO 13002186
Capital social subscris si varsat: 360.575 Lei
Nr. Operator Date Personale: 15862
Tel: 00 40 21 300 35 46, Fax: 00 40 21 300 35 54
E-mail: office@adecco.ro, Web: www.adecco.ro
BUCURESTI (HQ)- Doctor Iacob Felix Nr. 28, Sector 1, Tel.: 021/300 35 46; e-mail: recrutare@adecco.ro
ARAD - Mihai Eminescu nr. 45, Tel: 0257 / 281 147; E-mail: arad@adecco.ro
BRASOV - Str Petru Rares Nr 10; Tel.: 0040 - 372/70.57.95; e-mail: brasov@adecco.ro
CLUJ - Str. Vasile Lupu Nr 36 , Tel: 0264/ 406 234; e-mail: cluj@adecco.ro
IASI - Bld. Tutora Nr. 4, bl. B4 scara D, Tel: 0232 / 206 120; e-mail: iasi@adecco.ro
ORADEA - Str. Tudor Vladimirescu Nr 26; Tel.: 0040 - 727 735 160 e-mail: oradea@adecco.ro
PITESTI - Str. Fratii Golesti Nr. 57, etaj 2; Tel: 0248 / 612 303; e-mail: pitesti@adecco.ro
PLOIESTI - Str Mercurului Nr 1, Tel: 0244/ 519 320; e-mail: ploiesti@adecco.ro
SIBIU - Str. Vasile Milea Nr 11, Ap 57, Tel: 0269 / 206 450; e-mail: sibiu@adecco.ro
TIMISOARA - Str. Popa Sapca Nr. 12 tel: 0256/ 432 211; e-mail: timisoara@adecco.ro
