Director, US Regulatory Affairs

Site Name: USA - New Jersey - Warren Posted Date: Nov 3 2021 This position brings strategic regulatory leadership to OTC Drug products in the US portfolio. Trusted advisor to cross-functional partners, leads team to deliver well-constructed and considered regulatory strategies that meet consumer and business needs. Builds strong relationships with all stakeholders, internal and external. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Direct the strategy and execution of New Drug Applications for the portfolio, and actively manage the review and approval process, proactively seeking innovative and rapid path to market. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the regulatory environment. Key advisor on OTC Monograph interpretation for products within portfolio, providing guidance to business and other stakeholders. Lead interactions (meetings, teleconferences) with regulatory authorities in order to seek guidance, expedite approval of pending applications and to resolve regulatory matters. Key internal advisor on existing and emerging regulatory trends for products/categories in remit. Interpret regulatory actions and provide the business and R&D with robust analyses and recommendations for action. Actively leads as a member of task forces and committees of trade associations Responsible for providing leadership, motivation, training, coaching and mentoring for staff 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) Minimum of 10 years' experience in Regulatory Affairs 5 years experience in Consumer Health Strategic regulatory leadership experience Experience managing and leading teams Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD or Masters' degree in life sciences or pharmacy Experience with Over-the-Counter drug products Strong track record with leading successful FDA meetings Proficient writer - effectively use fact and narrative to communicate complex regulatory concepts Effective communicator, skilled at developing and maintaining key relationships with internal and external contacts 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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