Regulatory Affairs Manager – Ad/Promo SME & Product Specialist
IQVIA · Bucuresti, Romania · 4d ago
At IQVIA, our Global Regulatory Affairs team partners with pharmaceutical and biotechnology companies worldwide to navigate complex regulatory environments and support the successful development, approval and lifecycle management of healthcare products.
We are seeking an experienced Regulatory Affairs professional with significant expertise in Advertising & Promotion (Ad/Promo), promotional material review, labelling and artwork activities. This role combines technical regulatory leadership with involvement in customer proposals, bid defense support and cross-functional business development activities.
This is an excellent opportunity for a regulatory specialist who enjoys working at the intersection of compliance, stakeholder collaboration and customer-focused regulatory solutions.
What You'll Do
- Act as a subject matter expert for advertising and promotion, promotional material review, labelling and artwork-related activities.
- Review promotional and non-promotional materials to ensure alignment with approved product information and applicable regulatory requirements.
- Provide practical regulatory guidance on promotional claims, messaging, product information consistency and compliance expectations.
- Partner with medical, legal, commercial, quality, labelling and operational colleagues to identify and mitigate regulatory risks.
- Coordinate and deliver Ad/Promo regulatory review activities while ensuring high-quality, timely execution.
- Track deliverables, open issues, risks and project dependencies to support effective project oversight.
- Support proposal development, budget preparation, bid defense activities and customer responses as a Product Specialist.
- Coordinate input from regulatory experts and cross-functional stakeholders to develop compelling customer solutions.
- Contribute to customer-facing proposal content and support bid defense preparation and presentation activities.
- Translate complex regulatory requirements into practical, commercially relevant recommendations that support customer objectives.
What We're Looking For
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or another relevant scientific discipline.
- Extensive Regulatory Affairs experience within the pharmaceutical, biotechnology or healthcare industry.
- Strong hands-on experience in advertising and promotion (Ad/Promo), promotional material review, promotional compliance, labelling, artwork and related regulatory review activities.
- Strong understanding of promotional and non-promotional material review principles and regulatory compliance requirements.
- Experience partnering with medical, legal, commercial and operational stakeholders in a matrix environment.
- Excellent organisational skills with the ability to manage multiple priorities and coordinate diverse stakeholder groups.
- Strong communication and stakeholder management skills.
- Ability to work independently while maintaining a strong customer focus and delivery mindset.
Additional Experience That Will Help You Stand Out
- Experience supporting proposals, budgets, bid defense meetings or other pre-award activities.
- Broader lifecycle management or post-marketing regulatory experience.
- Experience gained within a CRO, consultancy or client-facing regulatory environment.
- Experience coordinating complex initiatives across multiple functions, countries or business units.
- Exposure to customer-facing interactions and presentation activities.
Why IQVIA?
Joining IQVIA means becoming part of a global community of regulatory experts helping pharmaceutical and biotechnology companies bring medicines to patients around the world.
In this role, you'll have the opportunity to:
- Develop and apply deep Ad/Promo regulatory expertise.
- Work with global pharmaceutical and biotech clients.
- Gain exposure to strategic proposal and business development activities.
- Collaborate with cross-functional experts across IQVIA.
- Contribute to innovative regulatory solutions in a fast-paced, international environment.
- Build a career pathway towards senior subject matter expert, Product Specialist leadership, Associate Director or broader Global Regulatory Affairs leadership opportunities.
If you are passionate about regulatory excellence, promotional compliance and helping customers navigate complex regulatory challenges, we would love to hear from you.
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.