- Location
- Bucuresti, Romania
- Type
- Full-time
- Department
- Legal
- Seniority
- Entry
- Education
- Bachelor
- Source
- Workday
Description
At IQVIA, our Global Regulatory Affairs team partners with pharmaceutical and biotechnology companies worldwide to navigate increasingly complex regulatory environments and accelerate patient access to innovative therapies. We are seeking an experienced Associate Director, Regulatory Affairs to provide strategic leadership across European regulatory activities while leading and developing a team of regulatory professionals across the region. This is an exciting opportunity for a regulatory expert who combines deep European regulatory knowledge with a passion for people leadership and client partnership.
What you'll do
- Lead and oversee complex European regulatory activities across the product lifecycle, including market applications, lifecycle management and post-marketing submissions
- Provide strategic guidance on European regulatory procedures, including Centralised, Decentralised, Mutual Recognition and National procedures
- Partner with clients as a trusted regulatory advisor, supporting regulatory strategy, governance discussions and decision-making
- Contribute to proposal development, bid defense meetings and business growth initiatives
- Lead, coach and develop Regulatory Affairs professionals within a global matrix environment
- Support resource planning, forecasting and operational excellence initiatives
- Drive continuous improvement while ensuring high-quality regulatory delivery
What we're looking for
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or a related discipline
- Extensive Regulatory Affairs experience with strong knowledge of European regulatory requirements and submission pathways
- Significant people management and leadership experience
- Experience supporting marketed products, post-marketing activities and lifecycle management
- Proven success managing complex regulatory programmes and stakeholder relationships
- Strong communication and presentation skills with the ability to influence internal and external stakeholders
- Commercial awareness and an interest in contributing to proposal development and business growth activities
Additional advantages
- Experience with biologics products
- CRO, consultancy or client-facing Regulatory Affairs experience
- Experience participating in proposal development or bid defense activities
Why IQVIA?
You'll join a global team of regulatory experts helping shape the future of healthcare while building and leading high-performing teams. This role offers broad exposure to regulatory strategy, commercial partnership and leadership opportunities, with potential progression into broader Global Regulatory Affairs leadership positions.
If you're passionate about regulatory excellence, people leadership and making an impact across Europe, we'd love to hear from you.
Apply today and help advance healthcare through smarter regulatory solutions.
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.
