Manager, Regulatory Advertising and Promotion Policy

Are you interested in using your knowledge of FDA regulations to provide sound regulatory advice on the advertising and promotion of prescription drug products and biologics in an effort to competitively position products for GSK? If so, the Manager role in Regulatory Advertising & Promotion Policy may be ideal for you.

As a Regulatory Advertising & Promotion Policy Manager, you will:

• Serve as internal expert on FDA regulations governing the promotion of assigned products
  • Provide Regulatory advice to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of competitive advertising and promotion for the US market in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy
  • Demonstrate leadership on promotional review teams such that recommendations are recognized as well-reasoned, valid and appropriate
  • Monitor OPDP activities and actions, assess impact and communicate information to stakeholders
  • Influence cross-functional US Pharma and R&D teams
  • Understand labeling for assigned GSK and competitor products
  • Ensure that changes in US prescribing information are reflected in current promotion and advertising

• Act as a credible, influential, respected spokesperson during interactions with the Office of Prescription Drug Promotion (OPDP) reviewers for assigned products
  • Ensure all advisory submissions to OPDP are complete, accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review
  • Develop appropriate and proactive communications with OPDP reviewers that help ensure expedient and efficient review of regulatory submissions
  • Establish and nurture a productive, transparent relationship with OPDP to achieve successful and timely review of advisory submissions and effective resolution of regulatory actions
  • Manage interactions with OPDP including response to regulatory inquiries or enforcement actions and discussions with OPDP staff on requested changes

The individual suited for this role will possess the capabilities to:

• Influence and persuade cross-functional promotional review teams on regulatory-related issues through strong interpersonal and listening skills
• Maintain strong customer focus and facilitate appropriate team decisions
• Evaluate and articulate regulatory risk to members of legal, regulatory, medical information, medical affairs, and the commercial organization
• Communicate clearly, accurately, and persuasively with reviewers within OPDP to identify and expedite resolution of issues relating to assigned products

Why you?

Basic Qualifications:

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

• Undergraduate degree in a biological or healthcare scientific discipline
• Experience in pharmaceutical/biologics regulatory, or scientific disciplines
• Experience in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents
• Demonstrated ability to multi-task and excel in cross functional settings and to manage multiple projects in a fast-paced environment.

Preferred Qualifications:

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

• Advanced degree in biological or healthcare scientific discipline
• Demonstrated history of successful interactions with FDA reviewers at OPDP
• Understanding of product development process, including clinical trial design, and labeling development process

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

*LI-GSK

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