Associate Director, Global Regulatory Affairs – Ad, Promo
Cambridge, New Jersey, United States of America
Full Time
4 hours ago
$166,000 - $203,000 USD
No H1B
About this role
Role Overview
- Review and approval of US promotional materials and medical communications
- Provide input and execute regulatory compliance/strategy related to promotional and advertising campaigns
- Liaise with OPDP/APLB (FDA) as needed for assigned product(s)
- Manage interactions with OPDP/APLB
- Develop processes and standards for promotional materials and related activities
- Provide regulatory training as needed
Requirements
- Minimum BS in scientific discipline
- Minimum of 8 years experience in the pharmaceutical industry
- Minimum of 5 years in regulatory affairs
- Expert knowledge of advertising promotion regulations and FDA Guidance documents
- Solid experience with promotional and medical review supporting product communications
- Experience in Oncology is a plus
Benefits
- competitive remuneration packages
- health insurance
- retirement plans
- paid time off
- professional development opportunities
- annual bonus
- equity