Associate Director, Regulatory Affairs – Advertising and Promotion

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the internal authority on FDA Advertising & Promotion issues for designated product(s), offering regulatory guidance and solutions to address comments on draft promotional materials.

• Evaluate and authorize promotional and medical content within Definium’s PromoMats system.

• Review and sanction social media content.

• Serve as the company’s representative to OPDP/APLB (FDA) regarding advertising and promotional materials.

• Oversee interactions with OPDP/APLB, manage regulatory inquiries, submit advisory comments, and engage in discussions with FDA personnel.

• Guarantee timely and accurate FDA 2253 submissions of US promotional materials.

• Ensure that changes in prescribing information are incorporated into promotional and advertising content.

• Create processes and standards for promotional materials and related activities.

• Deliver regulatory training on FDA requirements, PhRMA DTC Guidelines, company policies, and PRC processes.

• Offer regulatory support during the development of promotional plans from initial concept to field implementation, leading MLR review processes.

⛳️ Requirements

• Bachelor’s degree in a scientific discipline; advanced scientific degree preferred.

• At least 8 years of experience in the pharmaceutical sector, including a minimum of 5 years in regulatory affairs.

• In-depth knowledge of advertising and promotion regulations along with FDA Guidance documents.

• Technical expertise in various aspects of drug development and labeling.

• Strong background in supporting promotional and medical reviews for product communications.

• Experience collaborating with FDA OPDP and APLB on advertising and promotional topics.

• Experience in CNS is advantageous.

• Familiarity with Veeva PromoMats is a significant plus.

🏝️ Benefits

• Comprehensive health benefits fully covered, including Medical, Dental, and Vision for you and your dependents.

• 401(k) program with company matching and vesting starting after the first month post-hire.

• Flexible paid time off.

• Generous parental leave policy.

• A variety of enjoyable fringe benefits.

• Additional compensation options, including bonuses and equity, may be available.