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 guide...