Associate Director, Regulatory Advertising & Promotion Policy Job at GSK in Uppe

As an 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 :

Preferred Qualifications :

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

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https : / / openpaymentsdata.cms.gov /

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