Manager, Regulatory Affairs, Advertising & Promotion

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

📋 Description

• Oversee regulatory activities in the US related to the advertising and promotion of the company’s marketed products.

• Manage commercial initiatives with a regulatory focus on advertising and promotion, under the guidance of the Regulatory Affairs, Advertising & Promotion Director.

• Contribute to and provide advice 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.

• Review US and Global marketing materials and communications related to products and disease states.

• Collaborate effectively with Marketing, Medical Affairs, Legal, and other essential stakeholders.

• Build and maintain working relationships, managing communication with regulatory advertising and promotion professionals at partner companies involved in co-promotion.

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

• Maintain strong communication with FDA OPDP reviewers regarding advertising and promotion issues.

• Ensure compliance with FDA promotional material submissions on Form 2253.

• Monitor the external regulatory environment and provide advice to product teams on changing regulatory requirements.

• Keep track of FDA promotional enforcement activities and update stakeholders accordingly.

• Advise on how enforcement actions may impact company policies.

• Identify opportunities for process improvements in promotional review activities and standardization of portfolio-wide policies.

• Engage in cross-training across products and indications to guarantee consistent Regulatory A&P support.

• Work with Regulatory Therapeutic Area Leads to evaluate marketing application summary documents and study reports.

• Contribute input during review cycles to ensure commercialization objectives and messages are reflected in submission documents and reports.

• Provide input during the development and negotiation of labeling, focusing on commercialization objectives and messages related to promotion and advertising.

⛳️ Requirements

• A minimum of 2 years of relevant experience, ideally within Regulatory Advertising and Promotion.

• At least a Bachelor's degree from an accredited college or university in Life Sciences.

• Familiarity with regulations, guidelines, and precedents concerning pharmaceutical product development and marketing, particularly in advertising and promotion.

• Required experience with pharmaceutical products; experience with biologics is an advantage.

• Preferred experience working directly or indirectly with the FDA, particularly OPDP/APLB.

• Ability to review promotional materials and engage with FDA OPDP/APLB.

• Capability to support product launches and campaigns while demonstrating excellent written and verbal communication skills when providing strategic regulatory advice.

• Proficiency in supporting global promotional reviews.

• Understanding of clinical trial recruitment materials.

• Familiarity with labeling regulations is a plus.

• Ability to influence cross-functional teams and work collaboratively with colleagues at all organizational levels.

• Capability to interact with senior management when necessary.

🏝️ Benefits

• Annual bonuses or other incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• 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 required.