Manager, Regulatory Affairs Advertising Promotion
Site Name: USA - Massachusetts - Waltham, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence, USA - Pennsylvania - Philadelphia Posted Date: Apr 29 2021 As a Manager, Regulatory Affairs Advertising Promotion, 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. 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) reviewers for assigned products • Manage interaction with OPDP, including response to regulatory inquiries, preparation of complete, accurate, high quality submissions for advisory comments, and as needed discussion with OPDP staff • Participate in company working groups on advertising and promotion standards and guidelines • Ensure that changes in US prescribing information are reflected in current promotion and advertising • 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 research, guidance and enforcement activities, assess impact and communicate learnings to stakeholders • Influential member of multiple cross-functional US Pharma and R&D teams. Competencies and Capabilities : The individual will require strong interpersonal skills; good listening skills; demonstrated ability to influence and persuade others; customer focus and ability to facilitate appropriate team decisions Must be able to evaluate and articulate regulatory risk to members of legal, regulatory, medical information, medical affairs, and the commercial organization This position is expected to influence and persuade cross-functional copy approval teams for assigned products on regulatory-related issues This position is responsible for verbal and written communications with OPDP reviewers within FDA for assigned products; and therefore, must be able to effectively communicate orally and in writing in a way that clearly, accurately and persuasively communicates the issues 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 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 Demonstrated ability to multi-task and excel in cross functional settings and to manage multiple projects in a fast-paced environment Why GSK? Our values and expectations are 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. *LI-GSK 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 and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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