Regulatory Affairs Manager - Ad/Promo SME & Product Specialist

About the role

iQVIA's Global Regulatory Affairs team supports pharmaceutical and biotechnology companies worldwide in navigating complex regulatory environments. This role seeks an experienced regulatory professional with strong expertise in advertising and promotion (Ad/Promo), promotional material review, labelling and artwork. It combines technical regulatory leadership with involvement in customer proposals, bid defence support and cross-functional business development.

Key responsibilities

• Act as subject matter expert for Ad/Promo, promotional material review, labelling and artwork activities.
• Review promotional and non-promotional materials against approved product information and regulatory requirements.
• Give practical regulatory guidance on promotional claims, messaging, product information consistency and compliance.
• Partner with medical, legal, commercial, quality, labelling and operational colleagues to identify and mitigate regulatory risks.
• Coordinate and deliver Ad/Promo regulatory reviews, tracking deliverables, open issues, risks and project dependencies.
• Support proposal development, budget preparation, bid defence and customer responses as Product Specialist.
• Translate complex regulatory requirements into commercially relevant recommendations.

Required profile

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or another relevant scientific discipline.
• Extensive Regulatory Affairs experience in the pharmaceutical, biotechnology or healthcare industry.
• Strong hands-on experience in Ad/Promo, promotional compliance, labelling, artwork and regulatory review.
• Experience partnering with medical, legal, commercial and operational stakeholders in a matrix environment.
• Ability to work independently with a strong customer focus.

Required skills

• Understanding of promotional and non-promotional material review principles and regulatory compliance.
• Organisational skills to manage multiple priorities and coordinate stakeholders.
• Communication and stakeholder management skills.

Additional experience that helps: supporting proposals, budgets and bid defence; lifecycle management or post-marketing regulatory experience; CRO, consultancy or client-facing regulatory background; experience coordinating complex initiatives across functions, countries or business units; customer-facing presentation experience.