Associate Manager, Regulatory Advertising & Promotion

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

📋 Description

• Assist in the management of US regulatory activities related to the advertising and promotion of marketed products.

• Oversee commercial operations from a regulatory perspective in advertising and promotion, under the guidance of the Regulatory Affairs, Advertising & Promotion Director.

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

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

• Evaluate US and global product and disease-state materials and communication strategies.

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

• Manage interactions with regulatory advertising and promotion professionals at co-promote partner companies.

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

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

• Stay updated on evolving regulatory requirements for product and disease-state communications.

• Monitor FDA promotional enforcement activities and evaluate their impact on company policies.

• Facilitate process improvements and standardization of promotional review policies across the portfolio.

• Provide ongoing Regulatory Advertising and Promotion support to stakeholders.

• Collaborate with Regulatory Therapeutic Area Leads to review marketing application summaries and study reports.

• Support commercialization objectives and messaging in regulatory submission documents and reports.

• Work with management during the development of labeling and negotiations to align with commercialization objectives affecting promotion and advertising.

⛳️ Requirements

• A minimum of 1 to 2 years of experience in regulatory affairs, preferably in advertising and promotion, or completion of a Post-Doctoral Fellowship Program with related Regulatory Affairs experience.

• A Bachelor's degree (BS) from an accredited college or university in Life Sciences is required.

• An advanced scientific degree (Masters, PharmD, or Ph.D.) is strongly preferred.

• A solid understanding of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, focusing on advertising and promotion.

• Experience with pharmaceutical products is highly preferred; experience with biologics is an added advantage.

• Direct or indirect experience working with the FDA, particularly OPDP/APLB, is desirable.

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

• Ability to support product launches and marketing campaigns.

• Excellent written and verbal communication skills.

• Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations is preferred.

• Ability to influence and guide cross-functional teams effectively.

• Proficiency in interacting with senior management and colleagues across all levels.

🏝️ 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 accommodation during the recruitment process when required.