Regulatory Affairs Officer

  • Company: Through Executive Search by KPMG
  • Date posted: 14 May
  • Ref. Code: INT-RA-4914

Description / Requirements

Our client is a multinational Greek Pharmaceutical company.

 

Position requirements

  • Coordinates and participates in preparation of different types of regulatory submissions (e.g. dossier, variations, and scientific advice submissions) to competent authorities worldwide for approved and developmental products.
  • Contribute to and implement, execute the filing plan for relevant countries.
  • Preparation of registration files (Centralized, Decentralized, Mutual and National procedures)
  • Communication with public authorities regarding new registrations, variations and renewals as well as monitoring of labeling and packaging issues, ensuring adherence to legal requirements. 
  • Conducts proper assessments in order to anticipate questions and critical issues.
  • Reviews and updates CMC (chemical-manufacturing control) data.
  • Monitors and evaluates the impact of the local legislation changes of each country on business activities and guarantees organization readiness to address them proactively and aligns local regulatory affairs goals to strategic functional objectives.
  • Prepares and ensures regulatory submissions are made on time and meet company’s corporate and local regulatory requirements.

Candidate profile

  • University Degree in Biology, Chemistry or other related disciplines. A Master degree and / or any certification in a relevant field will be considered as an asset. 
  • Minimum 2 years of relative experience in Regulatory, R&D or Quality Control roles with experience in compiling Module 3 section of a dossier. 
  • Fluency in English both spoken & written. 
  • Strong analytical skills, detail oriented with excellent organizational and time management skills
  • Team player with the ability to interact effectively with all levels of the organization.

Remuneration

The company offers a competitive remuneration package and excellent career prospects within a developing and dynamic Pharmaceutical company.