Global Regulatory Ad & Promo Leader

Sobi; Waltham (MA); On-site; USD 260,000 - 290,000; Full time

Benefits offered by this job

Competitive compensation

Generous time off policy

Summer Fridays

Conferences attendance

Work-life balance

Collaborative environment

Impact on rare diseases

Job summary

Sobi is seeking a Head of Global Regulatory Advertising and Promotion in the United States. You will lead the regulatory strategy for all promotional and non-promotional materials, oversee FDA interactions, and own the global review process to ensure compliant, timely communications for our rare disease portfolio.

The role requires extensive experience in pharma advertising regulation, leadership of a multi-disciplinary team, and a collaborative approach to achieve business objectives while

Qualifications

• Advanced understanding of FDA promotional regulations and guidance documents.
• Experience leading regulatory ad&promo teams and processes.
• Strong cross-functional partnership with clinical, legal, and commercial teams.

Responsibilities

• Lead and direct post-marketing regulatory activities for US promotional and medical communications.
• Own the Global Material Review process and regulatory review for OPDP/APLB interactions.
• Develop and execute strategic initiatives and SOPs for regulatory advertising and promotion.

Skills

Regulatory Advertising & Promotion

People leadership

FDA compliance

Strategic planning

Cross-functional collaboration

Education

Minimum BS in scientific discipline

Advanced degree (PhD/MD/PharmD) or JD preferred

Job description

Sobi is seeking a Head of Global Regulatory Advertising and Promotion in the United States. You will lead the regulatory strategy for all promotional and non-promotional materials, oversee FDA interactions, and own the global review process to ensure compliant, timely communications for our rare disease portfolio.

The role requires extensive experience in pharma advertising regulation, leadership of a multi-disciplinary team, and a collaborative approach to achieve business objectives while