Regulatory Affairs Expert (Maternity Cover)

Εταιρεία

ManpowerGroup Greece, on behalf of its client, a multinational pharmaceutical company, is searching for an Regulatory Affairs Expert, who will be responsible for ensuring regulatory compliance, reporting to the Head of RA.

Workplace Location: Northern Suburbs of Athens, Remote work is offered
Working hours : 09:00-17:00
Contract duration : 12-14 months

Περιγραφή

Main responsibilities:
•Ensure preparation and submission of quality regulatory submissions with support from regulatory operations
•Ensure deadlines for different projects are met
•Maintain product labels and packaging in line with current registered authorization details according to the relevant local and EU legislation
•Ensure compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOPs & supporting systems)
•Keep abreast of the changes in regulatory legislation/guidelines
•Provide RA input by participation in internal working groups to meet company objectives
•Maintain and support communications with Health Authorities related to regulatory submissions

Candidate Profile:
•Proven working experience at least 3 years in Regulatory Affairs
•Bachelor’s/ Master’s Degree in Pharmacy, Biology, Chemistry or related Life Science
•General understanding of pharmaceutical product development and business needs
•Proficiency in the English Language
•Good knowledge of Microsoft applications and relevant IT-systems
•Ability to manage multiple tasks, projects, priorities, and complex systems simultaneously
•Ability to work in a matrix organization and participate effectively both independently and as part of multiple teams
•Ability to work under strict timelines, combined with flexibility when emergency situations require this
•Results oriented

Remuneration Package:
•Gross monthly salary
•Excellent training and development opportunities

Τόπος Εργασίας:

Greece

Διαθεσιμότητα:

Τύπος θέσης εργασίας:

Δημοσιεύτηκε:

18/08/2021

Κωδικός Εργασίας:

200396

Προβολές:

509

Όνομα Υποκαταστήματος:

Αριθμός ανοιχτών θέσεων εργασίας:

1
 
 

Regulatory Affairs Expert (Maternity Cover)

Greece
18/08/2021
200396
509
1

Εταιρεία

ManpowerGroup Greece, on behalf of its client, a multinational pharmaceutical company, is searching for an Regulatory Affairs Expert, who will be responsible for ensuring regulatory compliance, reporting to the Head of RA.

Workplace Location: Northern Suburbs of Athens, Remote work is offered
Working hours : 09:00-17:00
Contract duration : 12-14 months

Περιγραφή

Main responsibilities:
•Ensure preparation and submission of quality regulatory submissions with support from regulatory operations
•Ensure deadlines for different projects are met
•Maintain product labels and packaging in line with current registered authorization details according to the relevant local and EU legislation
•Ensure compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOPs & supporting systems)
•Keep abreast of the changes in regulatory legislation/guidelines
•Provide RA input by participation in internal working groups to meet company objectives
•Maintain and support communications with Health Authorities related to regulatory submissions

Candidate Profile:
•Proven working experience at least 3 years in Regulatory Affairs
•Bachelor’s/ Master’s Degree in Pharmacy, Biology, Chemistry or related Life Science
•General understanding of pharmaceutical product development and business needs
•Proficiency in the English Language
•Good knowledge of Microsoft applications and relevant IT-systems
•Ability to manage multiple tasks, projects, priorities, and complex systems simultaneously
•Ability to work in a matrix organization and participate effectively both independently and as part of multiple teams
•Ability to work under strict timelines, combined with flexibility when emergency situations require this
•Results oriented

Remuneration Package:
•Gross monthly salary
•Excellent training and development opportunities