Site Name: USA - Pennsylvania - Upper Providence, Home Worker - USA, Philadelphia Navy Yard, RTP, USA - Maryland - Rockville, USA - Massachusetts - Waltham
Posted Date: Jun 16 2022
GSK has a fantastic opportunity for a talented US Regulatory Affairs Associate 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.
As the Associate Director, Regulatory Advertising & Promotion Policy, you will be responsible for providing sound regulatory advice that minimizes the risk of regulatory and legal 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.
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.
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
• Serve as internal expert on FDA regulations governing the promotion of assigned products
• Act as a credible, influential, respected spokesperson during interactions with the Office of Prescription Drug Promotion (OPDP) and/or the Advertising and Promotional Labeling Branch (APLB) for assigned products
• Manage interaction with OPDP/APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP/APLB staff
• Participate in company working groups on advertising and promotion standards and guidelines
• 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
• Competitively position promotional materials that comply with applicable FDA regulations, policies and guidance
• Demonstrate leadership as the Regulatory reviewer on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate
• Monitor OPDP/APLB research, guidance and enforcement activities, assess impact and communicate learnings to stakeholders
• Influential member of multiple cross-functional US Pharma and R&D teams.
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
- 2+ years of experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents
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/APLB
- Understanding of product development process, including clinical trial design, and labeling development process
- Demonstrated ability to multi-task and excel in cross functional settings and to manage multiple projects in a fast-paced environment
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:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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