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About the role
Key responsibilities & impact- Manage US regulatory activities associated with advertising and promotion of the company’s marketed products
- Manage commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director
- Contribute to and advise on the development of product messages and materials across multiple functional areas
- Provide regulatory advice and guidance to Commercial teams and Medical Affairs regarding conference exhibit activities, disease awareness, and speaker programs
- Review US and Global product and disease state materials and communications
- Collaborate with Marketing, Medical Affairs, Legal, and other key stakeholders
- Establish working relationships and manage communication with regulatory advertising and promotion professionals at co-promote partner companies
- Help lead and assist in interactions with the FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions
- Maintain effective communication with FDA OPDP reviewers on advertising and promotion matters
- Ensure compliance with promotional material submissions to FDA on Form 2253
- Monitor the external environment and advise product teams on evolving regulatory requirements
- Monitor FDA promotional enforcement activities and update stakeholders
- Provide guidance on the impact of enforcement activities on company policies
- Identify process improvements for promotional review activities and portfolio-wide policy standardization
- Cross-train across products and indications to ensure continuous Regulatory A&P support
- Collaborate with Regulatory Therapeutic Area Leads to review marketing application summary documents and study reports
- Provide input during review cycles to reflect commercialization objectives and messages in submission documents and reports
- Provide input during labeling development and negotiation regarding commercialization objectives and messages impacting promotion and advertising
Requirements
What you’ll need- A minimum of 2 total years relevant experience, preferably within Regulatory Advertising and Promotion
- At minimum, a Bachelor's degree from an accredited college or university in Life Sciences
- Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in advertising and promotion
- Experience with pharmaceutical products required; biologics experience is a plus
- Experience working directly/indirectly with the FDA, specifically OPDP/APLB, is preferred
- Ability to review promotional materials and interact with FDA OPDP/APLB
- Ability to support launch products/campaigns while maintaining excellent written/verbal communication skill when giving strategic regulatory advice
- Ability to support global promotional review
- Understanding of clinical trial recruitment materials
- Familiarity with labeling regulations is desirable
- Ability to influence cross-functional teams and work collaboratively with colleagues at all levels
- Ability to interact with senior management if needed
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life, and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required