Description Overview

Scope of the Role

• Oversight for regulatory licencing and post marketing regulatory activities for all products registered and actively marketed in Hungary.
• Ensuring strategies and relationships with internal (e.g. GPS, CQA, Global Supply, CSCI Marketing, Commercial) and external stakeholders (e.g. competent authorities in Hungary, external consultants).
• Ensures company’s regulatory affairs activities are conducted according to relevant regulations, laws, and standards in the country.
• Oversees and support quality assurance and pharmacovigilance activities in the region to ensure compliance with relevant regulations. Ensure that an QA/PV operating model is maintained according to the business needs in the region.
• Ensure that optimal collaboration and ways of working are established and maintained with Corporate/ Global enabling functions
• Ensures appropriate basis for implementation of regional/ local marketing strategies are identified and/or implemented; assists in identification of advanced regulatory strategies for regulatory classifications within scope.
• Ensures that right processes and procedures are in place in the country.
• Being accountable for the RA budget planning and monitoring in the country.
  

Experience Required

• Minimum 7 years’ experience from the pharmaceutical/life science/selfcare industry, with a focus on regulatory affairs and understanding of quality assurance and pharmacovigilance as applying to OTC/ self-care products.
• Must have leadership experiences and change management skills.
• Ability to manage a team and direct reports in a hybrid model (on-site and remote.)
• Must have experience from launching new self-care products and interactions with external stake holders.
• Ability to manage cross-functional projects efficiently.
• Proactive and results-oriented: takes ownership, can work independently, has a can-do attitude