Regulatory Affairs Officer

Lavipharm is seeking a Regulatory Affairs Officer referring to the Lead Regulatory Affairs.

The role is accountable for ensuring that all products meet legislative requirements. Key duties of the job include: studying legislation, gathering, evaluating, organizing, managing and collating information necessary for the registration, maintenance and marketing of different type of products.

Requirements

Regulatory Documentation & Lifecycle Management

• Performs routine regulatory activities (i.e. renewals/variations/CTD sequence preparation)
• Monitors and sets timelines for license variations and renewal approvals
• Prepares Module 1 of the technical documentation required for registration of new pharmaceutical products and variations of existing products
• Prepares and submits to the Authorities any application needed for the importing/exporting of medicinal products
  
  

Regulatory Compliance & Monitoring

• Ensures that the company's products comply with the regulations of the regions where marketed
• Keeps up to date with national and international legislation, guidelines and customer practices
• Ensures compliance with the company’s policies and procedures
  
  

Packaging, Artworks & Promotional Materials

• Prepares and reviews packaging materials for product launch and/or compliance with legislation and guidelines for different types of products
• Ensures the timely preparation of the new/updated artworks
• Provides regulatory support for the preparation of promotional materials for the marketing department
  
  

Interaction with Regulatory Authorities & Cross-functional Support

• Interacts directly with regulatory authorities on defined matters related to variations and renewals
• Communicates with all departments to ensure and provide properly and effectively any regulatory support as required
  
  

Documentation & Systems Management

• Ensures the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of departmental activities
• Works with specialist computer software and resources
  
  

Other Responsibilities

• Carries out additional responsibilities related to the role as assigned by the Regulatory Affairs & Market Access Director and/or Chief Scientific Officer, ensuring alignment with company goals and vision