Director of Regulatory Ad & Promo Compliance

i-Pharm Consulting; Boston (MA); In loco; USD 225.000 - 250.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Vision insurance

401(k)

Descrizione del lavoro

A leading consulting firm in Boston is seeking a Director of Regulatory Affairs to oversee U.S. promotional review compliance. This role requires strong leadership and communication skills, along with extensive knowledge of FDA regulations. The position offers competitive compensation, with a salary range of $225,000 to $250,000, and the opportunity to influence strategy within a collaborative culture.

Competenze

• 5+ years of U.S. regulatory advertising & promotion experience in pharmaceuticals or biotech.
• Experience with marketed products and pipeline promotional review; launch experience preferred.
• Broad therapeutic area experience; rare disease, oncology, neuroscience, metabolic or bone preferred.

Mansioni

• Serve as the Therapeutic Area Lead and primary Regulatory Affairs representative.
• Review and approve U.S. promotional materials for compliance with FDA regulations.
• Act as the point of contact with the FDA, managing regulatory interactions.

Conoscenze

Leadership presence

Strong communication skills

Ability to influence without authority

Collaborative mindset

Knowledge of FDA promotional regulations

Understanding of OPDP interactions

Formazione

Bachelor’s degree

Advanced scientific degree

Descrizione del lavoro

A leading consulting firm in Boston is seeking a Director of Regulatory Affairs to oversee U.S. promotional review compliance. This role requires strong leadership and communication skills, along with extensive knowledge of FDA regulations. The position offers competitive compensation, with a salary range of $225,000 to $250,000, and the opportunity to influence strategy within a collaborative culture.