Regulatory Affairs Manager – Ad/Promo SME & Product Specialist (Pharmaceuticals)

Location: Bucuresti, Romania

Company

Global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Provide subject-matter expertise in advertising and promotion, promotional material review, labelling, and artwork activities.
• Review promotional and non-promotional materials for consistency with approved product information and regulatory requirements.
• Advise on promotional claims, messaging, product information consistency, and compliance expectations.
• Partner with medical, legal, commercial, quality, labelling, and operational stakeholders to identify and mitigate regulatory risks.
• Coordinate regulatory review deliverables, risks, dependencies, and project issues.
• Support proposal development, budget preparation, customer responses, bid defense activities, and presentations as a Product Specialist.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related scientific discipline.
• Extensive Regulatory Affairs experience in the pharmaceutical, biotechnology, or healthcare industry.
• Hands-on experience in advertising and promotion, promotional compliance, labelling, artwork, and related regulatory reviews.
• Strong understanding of promotional and non-promotional material review principles and regulatory compliance requirements.
• Experience collaborating with medical, legal, commercial, and operational stakeholders in a matrix environment.
• Strong organisational, communication, stakeholder management, prioritisation, and customer-focused delivery skills.

Nice to have

• Experience supporting proposals, budgets, bid defense meetings, or other pre-award activities.
• Lifecycle management or post-marketing Regulatory Affairs experience.
• Experience in a CRO, consultancy, or client-facing regulatory environment.
• Experience coordinating initiatives across multiple functions, countries, or business units.
• Customer-facing presentation experience.

Culture & Benefits

• Work with global pharmaceutical and biotechnology clients.
• Collaborate with cross-functional regulatory and business experts.
• Gain exposure to strategic proposals and business development activities.
• Contribute to regulatory solutions in an international environment.
• Potential career progression toward senior subject-matter expert, Product Specialist leadership, Associate Director, or broader Global Regulatory Affairs leadership roles.