Regulatory Affairs Senior Specialist, Lifecycle Management

The role is accountable for ensuring the appropriate licensing and maintenance of assigned products and development projects in line with company business objectives, relevant regulatory requirements and internal and external standards.

Job Responsibilities

• Responsible for the provision of regulatory support for assigned products across the full life cycle, from pre-launch, launch, maintenance, discontinuation and divestment
• Follows approval strategy and works proactively to ensure project completion
• Performs routine regulatory activities under minimum supervision (i.e. dossier maintenance/renewals/variations/CTD sequence preparation)
• Evaluates/Prepares Module 1 of the technical documentation required for variations of pharmaceutical products
• Maintains an up to date and developing knowledge of regulatory affairs legislation
• Prepares and reviews packaging materials for product launch and/or compliance with legislation and guidelines, for different type of products
• Interacts directly with regulatory authorities on defined matters including negotiating regarding marketing authorizations, variations and renewals
• Participates in regulatory compliance review projects/inspections
• Ensures the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities

Requirements

• BSc in a relevant area is required. Master of Science Degree (M.Sc.) is optional
• 3-5 years Regulatory Affairs experience in a pharmaceutical company
• Excellent command of the Greek and English language (written and spoken)
• Strong computer literacy