Senior Associate RA, Quality Assurance & Safety Surveillance based in Athens

Regulatory Affairs/Clinical Affairs Athens, Metamorfosi


Description

We are excited to be recruiting a Senior Associate Regulatory Affairs, Quality Assurance & Safety Surveillance to join our team based in Athens, Greece. This position will report directly to the Senior Regulatory Affairs Manager and will be tasked with assigned products to ensure their appropriate licensing, marketing and legal compliance, in Greece and Cyprus, and to control the safety, efficacy and quality of the products.

Main Responsibilities

Regulatory Affairs

  1. Handling the Life Cycle Management Activities for Medicinal Products, Medical Devices, Biocides, Food Supplements and Cosmetics, as part of the company’s portfolio.
  2. Preparing submissions of dossiers for initial MAA, renewals, variations to the National Competent Authorities (NCAs) for medicines and biocides and notifications for medical devices, cosmetics and food supplements.
  3. Handling RA software tools for LCM activities
  4. Analyzing the RA information and providing regulatory intelligence for both territories, EL & CY internally and centrally.
  5. Participating in key company’s meetings and working cross-functionally with central and local teams (marketing, innovation, supply, sales) to conclude on strategy for pipeline projects.
  6. Communicating with Health Agencies regarding license applications, variations, cancellations
  7. Project leadership
  8. Responsible for regulatory compliance for products assigned
  9. Keeping abreast of European and National legislation
  10. Packaging and promotional material review, claim oversight and artwork updates
  11. Networking with local trade associations and other key bodies
  12. Training colleagues as part of assigned projects

Quality Assurance & Safety Surveillance

  1. Responsible for quality and safety compliance for products assigned
  2. As part of the team, responsible for maintaining the Quality Management System up-to-date and assuring compliance of all departments to SOPs and policies.
  3. Recording deviations, investigating the root cause(s) and ensuring corrective/preventative actions to reduce non-conformities.
  4. Responsible for reporting and processing quality & safety complaints from end-users and HCPs for products assigned
  5. Responsible to reporting and processing medical enquiries requested by third parties for products assigned

Requirements: 

  • University degree in the fields of Pharmacy, Chemistry, Biology, Chemical Engineering or similar
  • Work experience 3 years at least in a similar position
  • Computer literate (Microsoft Outlook, Word, Excel)
  • Knowledge of regulatory requirements governing the company’s activities. Particular emphasis on Greek Health Authority requirements / procedures
  • Strong communication and interpersonal presentation skills, written and oral, in Greek & English
  • Analyzing Ability
  • Dedicated and committed team-player

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.

 

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.