Associate Director, Regulatory Affairs Advertising and Promotion

Responsibilities

• Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned products
• Review and approve promotional, medical, and social media materials in the PromoMats system
• Liaise with OPDP/APLB (FDA) as the single point of contact for advertising and promotional matters
• Manage FDA regulatory inquiries and prepare high-quality submissions for advisory comments
• Ensure timely and accurate FDA 2253 submissions of US promotional materials
• Ensure prescribing information updates are reflected in all current promotional and advertising materials
• Develop processes and standards to facilitate streamlined workflows for the review process
• Provide regulatory training on FDA requirements, PhRMA DTC Guidelines, and company policies

Requirements

• Minimum BS in a scientific discipline (advanced science degree preferred)
• Minimum 8 years of pharmaceutical industry experience
• At least 5 years of experience in regulatory affairs
• Expert knowledge of advertising promotion regulations and FDA Guidance documents
• Solid experience with promotional and medical review and working with FDA (OPDP, APLB)

Preferred Qualifications

• Experience in CNS (Central Nervous System) therapeutic areas
• Experience with Veeva PromoMats

Benefits

• 100% paid health benefits including Medical, Dental, and Vision for employees and dependents
• 401(k) program with company match
• Flexible time off
• Generous parental leave

About the Company

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders.