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About the role
Key responsibilities & impact- Contribute to management of US regulatory activities associated with advertising and promotion of marketed products
- Manage commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director
- Advise on development of product messages and materials across multiple functional areas
- Provide regulatory advice and guidance to Commercial teams and Medical Affairs regarding conference exhibits, 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
- Manage communication with regulatory advertising and promotion professionals at co-promote partner companies
- Assist with interactions with the FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions
- Maintain compliance with promotional material submissions to the FDA on Form 2253
- Monitor evolving regulatory requirements for product and disease-state communications
- Monitor FDA promotional enforcement activities and assess impacts on company policies
- Support process improvement and portfolio-wide standardization of promotional review policies
- Provide continuous 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 labeling development and negotiation to reflect commercialization objectives affecting promotion and advertising
Requirements
What you’ll need- A minimum of 1 to 2 years within regulatory affairs, preferably within advertising and promotion, or completion of a Post-Doctoral Fellowship Program with related Regulatory Affairs experience
- Minimum requirement is a Bachelor's degree (BS) from an accredited college or university in Life Sciences
- Advanced scientific degree (Masters, PharmD, or Ph.D.) strongly preferred
- Fundamental understanding of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, focused on advertising and promotion
- Experience with pharmaceutical products highly preferred; biologics experience is a plus
- Experience working directly or indirectly with the FDA, specifically OPDP/APLB, is desirable
- Ability to review promotional materials and interact with FDA OPDP/APLB
- Ability to support launch products and campaigns
- Excellent written and verbal communication skills
- Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations is desirable
- Ability to influence and guide cross-functional teams
- Ability to interact effectively with senior management and colleagues at all levels
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