GSK
Director, Regulatory Advertising & Promotion Policy
GSK, Durham, North Carolina, United States, 27703
Director, Regulatory Advertising & Promotion Policy
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
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).
Basic Qualifications
Bachelor Degree
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
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
Excellent communication skills, both written and verbal
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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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
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).
Basic Qualifications
Bachelor Degree
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
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
Excellent communication skills, both written and verbal
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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