Director, Regulatory Advertising & Promotion

The role is for a Director of Regulatory Advertising & Promotion at Sumitomo Pharma, focusing on overseeing advertising and promotional activities for pharmaceutical products, ensuring compliance with regulations, and providing strategic guidance within the Global Regulatory Affairs team.

Location: Remote (US)

Salary: $187,520–$234,400/yr

Responsibilities

• Review and approve advertising and promotional materials for compliance with regulations and company principles.
• Align strategies with regulatory colleagues to optimize product success.
• Develop and maintain relationships with colleagues and vendors involved in promotional material development.
• Oversee timely and accurate submission of promotional materials to regulatory agencies.
• Establish relationships with FDA's Office of Prescription Drug Promotion (OPDP).
• Serve as internal regulatory expert on FDA regulations, guidance, and enforcement trends.
• Create and review SOPs and department procedures.

Requirements

• 8–12 years of experience in biotech or pharmaceutical industry, with at least 8 years focused on regulatory advertising & promotion.
• Advanced degree preferred, preferably in a scientific discipline.

Benefits

• Merit-based salary increases.
• Participation in short incentive plan.
• Eligibility for 401(k) plan.
• Medical, dental, vision, life, and disability insurances.
• Unlimited paid time off, 11 paid holidays, additional time off during December shutdown.
• 80 hours of paid sick time annually.

Additional Information

• Position requires high level of autonomy, limited coaching, and mentoring.
• Candidate must have strong communication, organizational, and negotiation skills.
• Ability to work across locations and time zones, and adapt to changing priorities.
• Must be able to learn new therapeutic areas and make complex decisions.
• Confidentiality and compliance with all regulatory and legal standards are mandatory.