Regulatory Affairs Post-approval Senior Officer (Non-EU Markets)

About the role

Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, is looking for a Regulatory Affairs Post-approval Senior Officer (Non-EU markets) to join its team. The position is based in Athens, Kryoneri.

Key responsibilities

• Understand regulatory strategy and documentation requirements in Non-EU markets (Middle East, Africa, Asia, CIS, LATAM).
• Act as a responsible member of the Regulatory team on assigned regulatory projects.
• Assist and support junior team members on their projects.
• Collect, prepare and compile regulatory documentation for product lifecycle maintenance (administrative, quality, safety variations and renewals).
• Compile and monitor scientific responses to deficiencies raised by regulatory authorities.
• Liaise with international regulatory authorities, local agents and distributors.
• Ensure policies and procedures are understood, evaluated and followed, and investigate modifications where needed.
• Work with other departments to gather information for pharmaceutical dossier submission and product registration.
• Support internal regulatory compliance of registered products and prepare submissions, including CMC variation filings.

Required profile

• BSc degree in Chemistry, Biology or a relevant field.
• 2-4 years of experience managing regulatory submissions in Non-EU markets.
• Fluent English and good MS Office skills.
• Strong organisation, multi-tasking and deadline management, effective communication and relationship management.
• Ability to work under pressure and resilience.

Required skills

• Good command of eCTD software and CESP platform.
• Knowledge of EU and global regulatory guidelines.

What we offer

• Competitive salary and benefits.
• Continuous specialised training and career development.
• A friendly working environment.