Senior Regulatory Compliance Specialist

1 day ago

Athens, Attica, Greece beBeeRegulatoryAffairs Full time
Job Description

At one of the world's largest pharmaceutical manufacturers, we are seeking a talented Regulatory Affairs Post-approval Senior Officer to fill this pivotal role.

This position is based in Athens and requires an individual with expertise in regulatory strategy and documentation requirements. As a key member of our regulatory team, you will be responsible for assigned regulatory projects, ensuring timely completion and compliance with EU regulations.

You will also assist junior personnel with their projects, providing guidance and support as needed. Additionally, you will be responsible for preparing module 1 documentation for DCP, MRP, RUP, and National applications, as well as collecting, compiling, and monitoring regulatory documentation throughout the product lifecycle.

Furthermore, you will liaise with external regulatory authorities, ensure policies and procedures are properly understood and carried out, and support internal activities to guarantee regulatory compliance of registered products.

Requirements
  • Bachelor's Degree in Chemistry, Biology, or relevant field.
  • 2-4 years of experience in Regulatory Affairs/CMC within a Pharmaceutical organization.
  • Fluent English language skills and proficiency in MS Office.
  • Good command of eCTD software and CESP platform.
  • Strong organizational skills, multi-tasking, and ability to meet deadlines.
  • Effective communication and relationship management.
  • Knowledge of EU and global regulatory guidelines.
  • Ability to work under pressure and demonstrate resilience.
Benefits

The company offers competitive compensation, continuous specialized training, career development opportunities, and a friendly working environment.

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