IQVIA
Associate Regulatory Affairs Director, Europe SME
Romania · Work style not stated · Full time
Apply on the employer’s site ↗See how well you match this job
You apply directly with the employer. ROLIVA does not submit applications from this page and is not the employer.
About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerIQVIA
- LocationRomania
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
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
Show full description
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.
Check your resume against this job Free, no sign-up. Nothing you paste is stored.
Staying safe while you apply
- Never pay to apply, interview or accept an offer. ROLIVA never asks you for payment to apply to a job.
- Apply only through the official “Apply on the employer’s site” button, on the employer’s own site, and check that a recruiter’s email uses that employer’s own domain rather than a free email address.
- Be cautious of an offer made with no real interview, or pressure to decide quickly or share financial details early.
Does something look wrong with this listing? Use “Report broken link” in the role details, or read ROLIVA’s full job-safety guidance ↗.
Preparing for this role with ROLIVA
- Check the fit.
Compare the requirements with the experience you have confirmed, including gaps.
- Prepare honestly.
Build interview stories and application drafts from your own evidence.
- Keep track.
Save the role and record your own application status and follow-ups.
At a glance
- Employment typeFull time
- SeniorityEntry level
- Employer posted
- Added to ROLIVA
- Last checked