Lead Regulatory Affairs

Lavipharm Hellas, part of Lavipharm Group of Companies, is seeking a Lead Regulatory Affairs who will be accountable for planning, directing, coordinating activities so as to ensure compliance with regulations and standard operating procedures. The role is also accountable for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.

Responsibilities

Regulatory Strategy & Lifecycle Management

• Has responsibility for the provision of full regulatory support for assigned products across the full life cycle, from pre-launch, launch, maintenance, discontinuation and divestment
• Leads and performs internal policy reviews for global regulatory guidance and regulations
• Ensures sufficient regulatory resources are applied to project teams to meet project target dates
• Manages complex submissions making decisions independently and with minimum referral to Regulatory Affairs & Market Access Director
• Directs the preparation and submission of regulatory agency applications, reports, or correspondence
• Reviews all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
• Develops and performs routine regulatory activities (i.e. dossier maintenance/ renewals/variations/CTD sequence preparation)
  
  

Regulatory Compliance & Monitoring

• Formulates or implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Maintains current knowledge of relevant regulations, including proposed and final rules
• Ensures compliance with the company’s policies and procedures
• Ensures compliance with the company’s pharmacovigilance SOP and legislation
  
  

Packaging, Artworks & Promotional Materials

• Prepares and reviews packaging materials for product launch and/or compliance with legislation and guidelines
• Ensures the timely preparation of the new artworks
• Provides support for promotional materials
  
  

Interaction with Regulatory Authorities & Cross-Functional Support

• Interacts directly with regulatory authorities on defined matters including negotiating regarding marketing authorizations, variations and renewals
• Manages activities such as audits, regulatory agency inspections
• Communicates with all departments to ensure and provide properly and effectively any regulatory support as required
• Co-ordinates with R&D, Quality and Operations teams to ensure compliance with the relevant guidelines
  
  

Documentation & Systems Management

• Ensures the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department 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
  
  

Requirements

• BSc in a relevant area is required. Master of Science Degree (M.Sc.) is optional
• Minimum of 6 years Regulatory Affairs experience in a pharmaceutical company
• Excellent Knowledge of the Greek & English language
• Computer literacy
  
  

If you are ready to embark into challenging endeavors, be exposed to continuous learning opportunities, you are interested in the above position and only if you have the required qualifications, please reply, enclosing your curriculum vitae.