Director, Regulatory Advertising & Promotion Policy

Role Summary

Director, Regulatory Advertising & Promotion Policy. Lead regulatory advertising and promotion strategy for prescription drug products and biologics in the US, ensuring compliance with FDA regulations and GSK policy, and minimize regulatory risk. Serve as a spokesperson with OPDP/APLB and provide consultative support to Global Regulatory Affairs teams on development plans and commercial objectives.

Responsibilities

• Provide strategic and operational leadership to Marketing Brand Teams, Legal, Medical Affairs and Clinical in the development of advertising and promotion for the US market (for major company assets) in accordance with business goals and objectives, FDA regulation, PhRMA guidelines and company policy
• As an internal expert on FDA regulations governing promotion, maintain awareness of evolving regulations and interpretations, advisory comments, enforcement letters and policy issues, and communicate relevant information appropriately to stakeholders
• Establish and nurture a productive, transparent relationship with OPDP and/or APLB to achieve successful and timely review of advisory submissions and effective resolution of regulatory actions
• Advise on the development of US labeling to ensure support for anticipated promotional messages and claims
• In-depth understanding of labeling for assigned GSK and competitor products and the subsequent translation of that knowledge into the development of promotional materials
• Competitively position promotional materials that comply with applicable FDA and corporate regulations, policies and guidance
• Influential member of multiple cross-functional US Pharma, Regulatory Matrix Teams and R&D teams with senior membership
• Identify continuous improvement opportunities
• Participate in company working groups that focus on advertising and promotion standards and guidelines
• Serve as regulatory advertising and promotion lead on cross-functional matrix teams supporting early pipeline assets and pre-launch products for future promotional impact. Provide strategic advice on early assets, launch, and lifecycle product activities (e.g., clinical trial protocols, substantiation for claims, labeling review).

Qualifications

• Required: Bachelor Degree
• Required: 5 or more years of regulatory experience in the development of Pharmaceutical advertising and promotion for the US market (for major company assets)
• Required: Prior work experience interacting with OPDP and/or APLB reviewers
• Required: Experience working on pre-launch activities and launch promotional campaigns
• Required: Experience facilitating groups of individuals to work together on creating solutions
• Preferred: Advanced degree in biological or health care scientific discipline
• Preferred: 7 or more years of regulatory experience working on multiple products across a range of therapeutic areas
• Preferred: Demonstrated history of successful interactions with OPDP and/or APLB reviewers
• Preferred: Experience providing regulatory ad/promo consultations on target medicine profile, clinical trial designs and during labeling development
• Preferred: Consistent ability to foster strong matrix working
• Preferred: Proven track record of facilitating groups of individuals to work together on creating solutions
• Preferred: Ability to manage and execute on projects independently, with minimal supervision
• Preferred: Awareness/familiarity with digitalization in development and regulatory strategy to enhance decision-making, and drive efficiency and innovation
• Preferred: Excellent communication skills, both written and verbal

Skills

• Regulatory strategy and advisory
• FDA advertising and promotion regulations (OPDP/APLB)
• Labeling development and review
• Cross-functional leadership and stakeholder management
• Policy interpretation and compliance
• Communication and interpersonal skills
• Project management and independent execution

Education

• Bachelor Degree
• Advanced degree (preferred)

Additional Requirements

• Travel: Not specified
• Physical demands: Not specified