Regulatory Affairs Manager

We are seeking a Regulatory Affairs Manager for Greece (Athens or within a commuting distance to Athens as regular travels are mandatory) who will be responsible for submitting renewals, variations, post-market and market approvals, lifecycle management, to the Greek Health Authority.

Essential Functions

• Act as a Regulatory Manager on complex projects with guidance from senior staff, when appropriate.
• Write regulatory documents with minimal review by senior staff.
• Provide guidance to junior colleagues, including feedback on technical documents, and assist in their training and development.
• Present to clients at bid defense meetings, either by phone or in person, for a range of regulatory deliverables, as directed by senior staff.
• Write or propose revisions for new regulatory standard operating procedures, and/or act as a reviewer for these procedures, as assigned.
• Regularly travel to the Greek Health Authority in Athens.
  

Qualifications

• Bachelor's Degree or Master's Degree in Lifescience or related discipline.
• minimum 5+ years of relevant experience in post-marketing maintenance, lifecycle management regulatory affairs on Greek market.
• Specific regulatory or technical expertise and sufficient knowledge of managing regulatory projects and project deliverables in a timely manner.
• Strong communication and presentation skill as this is a client facing role.
• Expertise in planning and delivering work while maintaining quality standards.
• Knowledge of regulatory procedures in Greece, especially marketing authorization transfers and relevant cross-functional dependencies.
• Good working knowledge of regional regulatory intelligence.
• Experience in regulatory strategy, documentation requirements, timelines, and budgets for MATs and publishing projects.
• Native Greek as well as full working proficiency in English language.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is 44 200,00 € - 66 200,00 €. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.