Director, Regulatory Advertising & Promotion Excellence

Alkermes; Boston (MA); Presencial; USD 224.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Benefits package

Descripción de la vacante

Alkermes in the United States seeks a Director of Regulatory Affairs for Advertising and Promotion to provide regulatory advice on communications for Alkermes products and disease areas. You will collaborate with Marketing, Medical Affairs, Legal, and Sales to support brand initiatives and ensure compliance with FDA rules.

You will lead review processes, participate in cross-functional teams, and liaise with FDA as needed, while building internal relationships and training staff on FDA

Formación

• High level of applied knowledge of FDA laws, regulations, guidance, and industry standards.
• In-depth understanding of clinical trial design and interpretation of clinical data.
• Ability to communicate business issues across all levels and negotiate for compliant outcomes.

Responsabilidades

• Provide oversight of promotional materials for consistency with approved labeling and FDA guidance.
• Chair or participate in cross-functional regulatory and copy clearance committees.
• Maintain up-to-date knowledge of FDA requirements and advise departments accordingly.
• Provide FDA advertising and promotion training to employees and agents.
• Lead efforts to minimize complexity of review processes and improve efficiency.

Conocimientos

FDA compliance

Clinical trial literacy

Cross-functional collaboration

Regulatory strategy

Educación

Bachelor's degree in health or science

Descripción del empleo

Alkermes in the United States seeks a Director of Regulatory Affairs for Advertising and Promotion to provide regulatory advice on communications for Alkermes products and disease areas. You will collaborate with Marketing, Medical Affairs, Legal, and Sales to support brand initiatives and ensure compliance with FDA rules.

You will lead review processes, participate in cross-functional teams, and liaise with FDA as needed, while building internal relationships and training staff on FDA