Senior Regulatory Lead, Advertising & Promotion (Remote)

Servier Pharmaceuticals; Boston (MA); Híbrido; USD 150 000 - 170 000; Tempo integral

Resumo da oferta

Servier Pharmaceuticals, a Boston-based biopharmaceutical company, is seeking a Senior Manager, Regulatory Affairs – Advertising and Promotion. This role leads day-to-day regulatory review of US promotional materials and collaborates with Marketing, Medical Affairs, and Legal to ensure compliant messaging based on clinical data.

The position requires 5+ years in Regulatory Affairs focusing on advertising and promotion, with deep FDA knowledge and experience with Veeva Vault.

Qualificações

• Bachelor’s degree in a scientific or healthcare field required.
• 5+ years in Regulatory Affairs, focusing on advertising and promotion (biotech/pharma preferred).
• Strong knowledge of FDA regulations and guidance documents.
• Proficient with electronic document management systems and promotional review platforms (e.g., Veeva Vault).
• Ability to translate clinical data into compliant promotional messaging.
• Excellent interpersonal and cross-functional collaboration skills.
• Highly organized with experience supporting product launches.
• Proactive and solutions-oriented mindset.

Responsabilidades

• Lead regulatory review and approval of advertising, promotional, and disease state materials for US products.
• Ensure all promotional initiatives comply with FDA regulations and OPDP guidance.
• Represent Regulatory Affairs on PRC and MSRC for assigned products.
• Collaborate with Marketing, Medical Affairs, and Legal to shape product messaging.
• Prepare and submit FDA Form 2253 for US promotional materials.
• Provide regulatory guidance on conference exhibits and digital strategies.
• Monitor FDA enforcement actions and assess impact for stakeholders.

Conhecimentos

FDA regulations

Veeva Vault

Regulatory reviews

Cross-functional collaboration

Communications

Project management

Formação académica

Bachelor's degree in a scientific or healthcare field

Ferramentas

Veeva Vault

Descrição da oferta de emprego

Servier Pharmaceuticals, a Boston-based biopharmaceutical company, is seeking a Senior Manager, Regulatory Affairs – Advertising and Promotion. This role leads day-to-day regulatory review of US promotional materials and collaborates with Marketing, Medical Affairs, and Legal to ensure compliant messaging based on clinical data.

The position requires 5+ years in Regulatory Affairs focusing on advertising and promotion, with deep FDA knowledge and experience with Veeva Vault.