Senior Manager, Regulatory Affairs, Advertising & Promotion

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

📋 Description

• Oversee regulatory activities related to the advertising and promotion of marketed products and the commercial development of pipeline products on both a US and global scale, as applicable.

• Manage commercial activities from the perspective of regulatory advertising and promotion with minimal supervision.

• Provide guidance on the creation of product messages and materials across various functional areas.

• Offer regulatory advice and support to Commercial teams and Medical Affairs regarding conference exhibits, disease awareness initiatives, and speaker programs.

• Evaluate US and Global product and disease-state materials and communications to ensure compliance with relevant laws, regulations, and guidelines.

• Work collaboratively with Marketing, Medical Affairs, Legal, and other essential stakeholders.

• Develop working relationships and manage communication with regulatory advertising and promotion experts at co-promote partner companies.

• Lead interactions with the FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions.

• Ensure compliance with promotional material submissions to the FDA using Form 2253.

• Keep abreast of changing regulatory requirements related to product and disease-state communications.

• Track FDA promotional enforcement actions and advise stakeholders on their implications.

• Contribute to process enhancements and portfolio-wide standardization of promotional review policies.

• Engage in cross-training across products and indications to guarantee ongoing Regulatory Advertising and Promotion support.

• Collaborate with Regulatory Therapeutic Area Leads on marketing application summary documents and study reports.

• Assist in review cycles to align commercialization objectives and messages in submission documents and reports.

• Provide input during the development and negotiation of labeling to reflect commercialization goals and messages affecting promotion and advertising.

⛳️ Requirements

• A minimum of 3 to 4 years of experience in regulatory affairs, particularly in advertising and promotion.

• At least a Bachelor’s degree from an accredited College or University in Life Sciences.

• Regulatory experience can compensate for educational requirements.

• In-depth knowledge of regulations, guidelines, and precedents concerning pharmaceutical product development and marketing, especially regarding advertising and promotion.

• Experience with pharmaceutical products is essential; experience with biologics is advantageous.

• Prior experience working directly or indirectly with the FDA, particularly with OPDP/APLB, is preferred.

• Capability to review promotional materials and interact with FDA OPDP/APLB.

• Experience managing product launches and campaigns.

• Exceptional written and verbal communication skills for providing strategic regulatory advice.

• Ability to support global promotional review processes.

• Understanding of clinical trial recruitment materials.

• Familiarity with labeling regulations is desirable.

• Proficiency in influencing cross-functional teams and engaging with senior management.

🏝️ Benefits

• Annual bonuses or other incentive programs.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company matching.

• Health and wellness programs.

• Access to fitness centers.

• Comprehensive medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Reasonable accommodations during the recruitment process, as needed.