Senior Manager Regulatory Affairs - OTC

Site Name: USA - New Jersey - Warren Posted Date: Apr 1 2022 Are you interested in a highly-visible US Regulatory Affairs - OTC role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Manager could be an ideal opportunity to explore. As a Regulatory Affairs Manager, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US. This position has responsibility for strategic end-to-end regulatory activities for the assigned portfolio. Develops and executes well-constructed and considered regulatory strategies that meet consumer and business needs. Builds strong relationships with all stakeholders. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Growth: Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market. Collaborate with Global and US stakeholders (commercial, Global Reg, R&D etc) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and POS Deliver Regulatory support and guidance to ex-US markets for brands where US is the Lead Market (as defined through SRA) Participate in interactions (meetings, teleconferences) with regulatory authorities in order to seek guidance, expedite approval of pending applications. Stewardship: Accountable for the ongoing end-to-end regulatory compliance of products in remit. Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated. Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business. Maintain high level of knowledge on the science of products within defined portfolio. Monitor and analyse regulatory environment for trends, possible threats and opportunities. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree 8 + years of experience in Regulatory Affairs 3 + years in Consumer Health - OTC (over the counter) Experience with US regulatory environment Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline RAC certification Experience at a large global pharmaceutical or vaccines company 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. 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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