Regulatory Affairs Manager – Ad/Promo SME & Product Specialist
Core
Subject matter expert for advertising and promotion, promotional material review, labelling, and artwork activities within the pharmaceutical and biotechnology industry.
Role type
Senior Regulatory Affairs Manager (Ad/Promo SME & Product Specialist)
Builds
Regulatory-compliant promotional materials, customer proposals, and bid defense solutions for pharma/biotech clients.
Domain
Life Sciences / Healthcare Regulatory Affairs
Required skills
Ad/Promo regulatory expertise, promotional material review, labelling and artwork compliance, stakeholder collaboration, project oversight, proposal development, bid defense support, cross-functional coordination, commercial regulatory strategy
Preferred skills
Lifecycle management experience, CRO/consultancy background, complex multi-country initiative coordination, customer-facing presentation skills
Technologies
Regulatory review platforms, proposal management tools, bid defense systems
Responsibilities
Review promotional and non-promotional materials for regulatory alignment; Provide guidance on promotional claims and messaging; Partner with medical, legal, and commercial teams to mitigate risks; Coordinate Ad/Promo review activities and track project dependencies; Support proposal development and bid defense activities; Translate regulatory requirements into commercially relevant recommendations
Seniority
Senior, hands-on IC with strategic proposal involvement