As the Director, Regulatory Advertising & Promotion Policy, you will be responsible for leading assigned products providing sound regulatory advice for advertising and promotion of prescription drug products and biologics that minimizes the risk of regulatory action, competitively positions assigned products and is consistent with applicable FDA regulations and GSK policy.
This role will act as a credible, influential, respected spokesperson for assigned products during interactions with the Office of Prescription Drug Promotion (OPDP) and/or the Advertising and Promotional Labeling Branch (APLB) reviewers. The Director will provide consultative support to Global Regulatory Affairs therapeutic project teams for issues/strategies relating to continuity between development plans and commercial objectives.
Key Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.
• 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).
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
5 or more years of regulatory experience in the development of Pharmaceutical advertising and promotion for the US market (for major company assets)
Prior work experience interacting with OPDP and/or APLB reviewers
Experience working on pre-launch activities and launch promotional campaigns
Experience facilitating groups of individuals to work together on creating solutions
Excellent communication skills, both written and verbal
Preferred Qualifications:
Advanced degree in biological or health care scientific discipline
7 or more years of regulatory experience working on multiple products across a range of therapeutic areas
Demonstrated history of successful interactions with OPDP and/or APLB reviewers
Experience providing regulatory ad/promo consultations on target medicine profile, clinical trial designs and during labeling development
Consistent ability to foster strong matrix working.
Proven track record of facilitating groups of individuals to work together on creating solutions
Ability to manage and execute on projects independently, with minimal supervision
Awareness/familiarity working with the digitalization in development and regulatory strategy to enhance decision-making, and drive efficiency and innovation
#LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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