Site Name: USA - New Jersey - Warren Posted Date: Oct 27 2021 As a Sr. Associate in Regulatory Affairs, you will execute well-constructed and considered regulatory strategies that keep pace with the dynamic FDA submissions and OTC Monograph regulatory environment including novel innovation areas in self-care. 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: Growth: Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph, NDA). Recommend and execute regulatory strategies for the portfolio, 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 Provide support to ex-US markets for brands where US is the Lead Market (as defined through SRA) Stewardship: Support 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. External Engagement: Monitor regulatory trends that could impact portfolio 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) 2 + years experience in a pharmaceutical or consumer health environment, Preferred Qualifications: If you have the following characteristics, it would be a plus: Regulatory Affairs experience is a plus 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness *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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