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