Remote working arrangements may be considered for US candidates not local to our US campuses.
We have a fantastic opportunity as a talented US Regulatory Affairs Director
with strong regulatory affairs advertising and promotion experience to work on vaccines and/or pharmaceutical products in cutting edge areas of science. This represents an exciting opportunity to be part of GlaxoSmithKline (GSK), who is committed to innovative scientific research and discovery to help people do more, feel better, live longer. Global Regulatory Affairs (GRA)
Our Global Regulatory Affairs organization plays a critical role in enabling delivery of innovative biopharmaceuticals to patients. As an integrated Global Regulatory Affairs team, our regulatory functions drive business-aligned, innovative regulatory strategies related to the discovery, development, registration, commercialization, and lifecycle management of products (pharmaceuticals and vaccines) that maximize the value of the R&D pipeline and our existing product portfolio in markets around the world. We also operate a continuous learning organization that recognizes the importance of proactive efforts to shape the evolving external regulatory environment in order to enable novel regulatory pathways for our portfolio of medicines. Regulatory Advertising & Promotion Policy (RAPP), US Regulatory Affairs
We are trusted Regulatory advertising and promotional experts who are accountable for making sound regulatory decisions that enable the organization to deliver high quality promotional materials and executions that educate our patients and customers and drive performance. We operate in an environment of trust, openness to feedback, and collaboration.
We operate as a team with a leadership mindset and foster an inclusive environment where team members' individual strengths are recognized and given visibility and there are expanding opportunities to develop a breadth and depth of regulatory expertise and leadership skills.
We view challenges as opportunities to explore new ideas to better our team and the organization.
We release energy whenever possible and support work life balance because we respect and value each other as Individuals . The Role - Director, Regulatory Advertising & Promotion Policy
As the Director, Regulatory Advertising & Promotion, 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 and legal action, competitively positions assigned products and is consistent with applicable FDA regulations and GSK policy. You 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Why You? Basic Qualifications:
- 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, ICH guidelines, PhRMA guidelines and company policy
- Internal expert on FDA regulations governing the promotion of assigned products
- 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 and R&D teams with senior membership
- Identify continuous improvement opportunities
- Maintain a deep and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry and communicate relevant information appropriately to stakeholders
- Participate in company working groups that focus on advertising and promotion standards and guidelines
- Provide input on promotional implications of proposed clinical study designs, as appropriate
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree & experience in pharmaceutical/biologics regulatory, or scientific disciplines
- Experience in the review of prescription drug advertising and promotion for compliance with applicable US FDA laws, regulations and guidance documents
- Experience as a primary reviewer on promotional review teams
- Experience working in cross-functional settings
- Experience anticipating issues and providing mitigating solutions to help optimize development of quality promotional materials/programs
- Experience managing and executing on projects
If you have the following characteristics, it would be a plus:
- Advanced degree in biological or health care scientific discipline
- Preferred knowledge and experience in advanced areas of science
- 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
- Experience working on pre-launch activities and launch promotional campaigns
- Demonstrated experience of working on multiple products across a range of therapeutic areas
- Experience successfully leading multidisciplinary matrix teams
*LI-GSK Why GSK ?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK
with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, technology and talent to get ahead of disease together
- all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing.
So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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