regulatory affairs associate manager.

For the Regulatory Affairs Associate Manager position the company offers the following benefits: 

• opportunity for further career evolution.
• modern working environment.
• competitive remuneration package.

The ideal candidate for the Regulatory Affairs Associate Manager position will be responsible for:

• Under supervision make submissions to the national authority & follow upaccordingly. Prepare local submission documents.
• Perform local tasks related to EU centralized licenses e.g translations.
• Reg Info management including systems update internal & external.
• Product information (SmPC/aPI/PIL/aRMM) & artwork management.
• Make the approved Summary of Product Characteristics (SmPC) or/and theleaflets, available internal and external use.
• Maintain training compliance & help co-workers understand the impact ofappropriate training.
• Liaise with PV, QA, SC, participate in local affiliate meetings.
• Participate in project teams as needed.
• Perform GxP tasks e.g. PQR review & follow procedures.
• Under supervision communicates with local HA.
• Begin to develop (or maintain) external relationships and network acrossother companies.
• Monitor, apply and communicate local regulatory intelligence within EST- RA and within the affiliate.
• Review promotional materials in line with local code.
• Work on project teams to implement improvements & update SOPs.
• Understand and interpret scientific data and make recommendations.
• Submit promotional materials to the Health Authority.

The qualifications for the Regulatory Affairs Associate Manager position include:

• Bachelor or Master Degree, preferably in a life science subject.
• Basic understanding of regulatory affairs and the regulatory landscape within the EU.
• Proficiency in local and English language.
• Strong aptitude to build knowledge and support a team. 
• Demonstrable attention to detail.

• 1-2 years of Regulatory Affairs experience would be considered an asset. 

Does this role sounds like you or someone you know? We want to hear from you today. Apply online now!

Have some questions first? Call our office at +30 2166001308 and ask for Calypso Aronis. Otherwise, feel free to contact me at caronis@randstad.gr. 

Please note that for transparency and equity reasons, only those applications made online via our site will be assessed. After the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. ​ All applications are considered strictly confidential.