Review medical education and commercial advertising and promotional materials to ensure compliance with applicable regulatory requirements
Serve as a regulatory reviewer on the Medical, Legal, Regulatory (MLR) committee and/or Medical Review Committee (MRC) teams
Assist with 2253 submissions
Monitor competitor space advertising and promotion materials
Provide strategic input on campaigns for compliant product communications
Identify MLR/MRC process or system improvements
Articulate complex regulatory issues to project teams and external stakeholders
Implement strategies to ensure programs are within the framework of published guidance documents
Assist with managing budgets for functional area
Develop relationships with external parties (e.g., CROs, consultants) and stay current on industry trends

Bachelor’s or M.S./Ph.D. degree in scientific area
Minimum of 12 years with a Bachelor’s, or 10 years with an MS/PhD of relevant Regulatory Affairs experience in a biotech / pharmaceutical setting
Minimum of 8 years supervisory experience
Thorough knowledge of FDA advertising and promotion regulations and guidance
Experience with MLR or promotional review committees supporting product communications and managing regulatory submissions of promotional materials
Experience and understanding of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA regulations
Excellent negotiation skills
Excellent written and oral communication skills
Strong organizational skills, including the ability to prioritize workload
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint)

discretionary annual target bonus
stock options
ESPP
401k match
health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
winter company shutdown

Director, Regulatory Affairs – Advertising and Promotion

Key skills