•Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries
•Submit submissions such as renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority and EMA and follow up on the local regulatory approval process for designated countries
•Preparation of local Product Labelling (e.g. SmPC, PIL), in local language for designated countries
•Artwork review and approval in client systems
•Manage multiple pharmaceutical products
•Act as subject matter expert in regulatory processes
• Acts as a Regulatory Team Leader on more complex projects, which may include authoring of regulatory documentation, filling application forms.
• Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned and discuss customer comments
• Acts as a Subject matter expert in Regulatory knowledge in Chemistry, Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.
• Project budget management
• Give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development
• possible exposure to present to clients on complex regulatory processes bid defense meetings
• Act as reviewer for regulatory standard operating procedures
• Prepare and deliver internal regulatory training if required