Associate Director, Regulatory Affairs Advertising and Promotion

About the role

This role supports regulatory review and activities related to advertising/promotion of our marketed pharmaceutical products in oncology, endocrinology, hematology. Key responsibilities include direct regulatory review of US/Canadian commercial product and disease state materials/communications, ensuring promotional materials meet regulatory and company requirements, and coordinating cross-functionally to drive resolution of issues impacting promotional activities.

Responsibilities

• Direct regulatory review of US / Canadian commercial product and disease state materials/communications
• Ensures promotional materials meet ad/promo regulatory and company requirements
• Ensures timely review of materials to meet internal timelines, requirements, and compliance with approved product labels
• SUBMIT PRODUCT PROMOTIONAL MATERIALS TO OPDP (OFFICE OF PRESCRIPTION AND DRUG PROMOTION) ON FORM FDA 2253 IN A TIMELY MANNER AS PER REGULATIONS, AND ENHANCES MATERIALS ARCHIVING PER COMPANY POLICY
• COORDINATES CROSS-FUNCTIONALLY AND DRIVES TO RESOLUTION ISSUES THAT IMPACT PROMOTIONAL ACTIVITIES
• POLICY INSIGHTS AND GUIDANCE TO MULTIPLE FUNCTIONAL AREAS ON THE DEVELOPMENT OF PRODUCT MESSAGES, ASSETS, PROGRAMS, TACTICS, ETC.
• REVIEW CONCEPTS, MATERIALS, AND COMMUNICATIONS USED IN SCIENTIFIC EXCHANGES; REPRESENT REGULATORY AFFAIRS ON THE MEDICAL REVIEW COMMITTEE (MRC)
• MANTAINS UP-TO-DATE KNOWLEDGE OF LAWS, REGULATIONS, AND POLICIES ENFORCED BY FDA AS THEY RELATE TO AD/PROMO
• HANDLES ADDITIONAL DUTIES AND SPECIAL PROJECTS, AS ASSIGNED BY THE DIRECTOR OF RA AD/PROMO
• CONTINUOUSLYASSES AD/PROMO-RELATED PROCESSES TO ENHANCE EFFICIENCY AND COMPLIANCE
• MONITORS COMPETITOR ADVERTISING TO KEEP ADEPOTENT OF MARKET PROMOTIONAL AND ADVERTISING STRATEGIES. ASSISTS IN ASSESSING COMPETITOR MATERIALS FOR POTENTIAL VIOLATIONS
• MONITORS OPDP ENFORCEMENT ACTIONS AND ASSESSES POTENTIAL LEARNINGS / IMPACT

Requirements

• Bachelor’s degree required and preferred in a science discipline (e.g. biology); 8+ years of relevant pharmaceutical industry and 4 years of direct advertising and promotion review experience
• Experience preparing and submitting regulatory documentation to FDA
• Experience preferred in rare diseases

Qualifications

• Thorough understanding of applicable laws, regulations, and FDA guidance related to ad/promo
• Demonstrated ability to conduct independent review of materials and tactics
• Demonstrated record of functional representation on committees, strong interpersonal and communication skills
• Solid understanding of the structure and function of product labeling
• Strong organizational skills and attention to detail
• Proficiency reviewing and annotating in Veeva PromoMats (or comparable system) and experience with MS Office (Outlook, Teams, Word, Excel, PowerPoint)
• Familiarity with eCTD requirements and e-submission formats/processes of promotional materials
• Demonstrated ability to manage multiple competing priorities

Skills

• Understanding of applicable laws, regulations, and FDA guidance related to ad/promo
• Independent review of materials and tactics
• Functional representation on committees, strong interpersonal and communication skills
• Solid understanding of the structure and function of product labeling
• Organizational skills and attention to detail
• Proficiency reviewing and annotating in Veeva PromoMats (or comparable system) and experience with MS Office (Outlook, Teams, Word, Excel, PowerPoint)
• Familiarity with eCTD requirements and e-submission formats/processes of promotional materials
• Ability to manage multiple competing priorities

Benefits

• Health Insurance: Medical, dental, orthodontia, vision, life & ADD, short and long-term disability insurance benefits
• Retirement Benefits: 401k
• Paid Time Off: Vacation, holiday, and sick/personal time