Sr. Manager, Regulatory Affairs Rx to OTC Switch
Site Name: USA - New Jersey - Warren Posted Date: Nov 2 2021 The Sr. Manager Regulatory Affairs - RX to OTC Switch will play an important role progressing switch opportunities. The purpose of this role is to support the activities of the Switch team by developing and executing robust regulatory strategies that leverage advancing science and research techniques. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Develop and execute regulatory strategies in support of IND and NDA submissions for Switch opportunities Draft and evaluate OTC Drug Facts Labels, Consumer Information Leaflets, and behavioral support materials to ensure they meet regulatory requirements and consumer needs Advise on design of assigned development programs, including label comprehension studies, self-selection studies, actual use trials and tailored consumer studies. May include oversight of study execution. Oversee development of all sections of assigned applications, to ensure consistent messaging an on time delivery. Primary author for Module 1. Identify data needs and develop specialized research to support product approval and marketing claims Lead preparation for meetings with regulators, other policy makers and stakeholders, including preparing reports, presentations and manuscripts Drive GSK NSURE agenda, collaborating with internal stakeholders and external experts to make a positive impact on consumer comprehension, selection, access models and compliant use of new products. For new switch opportunities, support Switch team with comprehensive regulatory assessment of feasibility based on a comprehensive assessment of the science and the issues likely to be raised by the switch Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering); Social Sciences with commensurate experience. 8 + years' experience in Regulatory Affairs, 5 in Consumer Health. Other relevant behavioral experience will be considered. Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering); Social Sciences with commensurate experience. Social Sciences/Research and/or FDA experience are highly desirable for this role. 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. At GSK, the health and safety of our employees are of paramount importance. 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