Manager/Associate Director, Regulatory Advertising and Promotion Policy at GSK in Philadelphia, PA

As a Manager/Associate Director, Regulatory Advertising & Promotion Policy, you will be responsible for providing sound regulatory advice that minimizes the risk of regulatory action, competitively positions assigned products and is consistent with applicable FDA regulations and GSK policies for advertising and promotion of prescription drug products and biologics.

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 Regulatory advice to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the review and development of advertising and promotion for the US market in accordance with business goals and objectives, FDA regulation, PhRMA guidelines and company policy
• Knowledge of FDA regulations governing the promotion of assigned products
• Competitively position promotional materials that comply with applicable FDA regulations, policies and guidance
• Interactions with OPDP/APLB, including supporting responses to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments
• Assist on the development of US labeling to ensure support for anticipated promotional messages and claims
• Understanding of labeling for assigned GSK and competitor products
• Participate in company working groups on advertising and promotion standards and guidelines
• Monitor OPDP/APLB research, guidance and enforcement activities, assess impact and communicate learnings to stakeholders
• Member of multiple cross-functional US Pharma, Regulatory Matrix Team, and R&D teams Capabilities
• Strong communication skills, both written and verbal
• Demonstrated ability to excel in cross functional settings and to manage multiple projects in a fast-paced environment
• Understanding of drug development, including clinical trial design and labeling development
• Proficient in digital fluency capabilities to enhance project delivery and drive efficiency and innovation

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Bachelor Degree
3 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:

If you have the following characteristics, it would be a plus:

Advanced degree in biological or health care scientific discipline
5 or more years of regulatory experience working on multiple products across a range of therapeutic areas
Experience providing regulatory ad/promo consultations on target medicine profile, clinical trial designs and during labeling development
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

#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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