Regulatory Affairs Officer

Adelco SA
is a leading pharmaceutical company committed to developing, manufacturing, and delivering high-quality medicines that improve lives. We are currently seeking a motivated and detail-oriented
Regulatory Affairs
Officer
to join our RA team and contribute to maintaining compliance with regulatory standards and internal quality policies.

Responsibilities

• Supervise and maintain accounting books (Category C) in accordance with Greek GAAP and tax regulations
• Acting as responsible Regulatory Team member for assigned regulatory projects (new submissions, variations, renewals etc).
• Supporting the Implementation of the Regulatory strategy projects in Greece and in export countries and understanding relevant documentation requirements as per legislation applied in each county of interest.
• Review regulatory documentation for DCP and National applications in line with assigned timelines paused from authorities.
• Preparation of administrative documentation (mainly module 1) for submissions in Greece and abroad/export countries according to regulatory planning & regulatory strategy.
• Update the labelling product information (mock ups) as per each country requirements and applied legislation.
• Liaise with external Regulatory authorities in Greece and abroad, as required for each regulatory project.
• Ensure new released policies and procedures are well understood, evaluated and carried out for regulatory and labelling projects.
• Liaise properly and effectively with various manufacturing departments (QC, QA & Production) for timely collecting all necessary information and needed documentation, in accordance with defines guidelines for pharmaceutical products dossier submission and gaining product registration/marketing authorisation.
• Support life-cycle management activities in order to ensure continues regulatory compliance of registered products and or new products under registration.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• 2–3 years of experience in a Regulatory Affairs role within the pharmaceutical or biotechnology industry.
• Strong communication skills in English (written and verbal).
• Excellent attention to detail and organizational skills.
• Ability to work under pressure, solve problems, and take initiative.
• Strong organization skills, multi-tasking and able to meet defined timelines. .

We offer

• Competitive remuneration package, based on qualifications and experience.
• Modern and pleasant working environment.
• Opportunities for career advancement and leadership roles.
• Ongoing training and skill development.