Site Name: USA - North Carolina - Research Triangle Park, USA - Maryland - Rockville Posted Date: Aug 20 2021 Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK? If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore. As Regulatory Affairs Operations Manager, you will manage multiple projects and teams simultaneously and will provide assessments (metrics, data) and conclusions/action plans within and across departments. You'll identify risks associated with submission data and information packages, and lead in the creation, maintenance and continuous improvement of Regulatory processes, policies and systems. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… You will maintain organizational networks within and outside GSK at local level (e.g., maintains relations with Local site leadership). Serve as the escalation contact for regulatory associates located in the Center. You will recruit, lead and motivate staff within and across teams on assigned tasks for global teams. Be responsible for identifying and escalating (as appropriate) risks associated with regulatory deliverables Based on strategy from the regional team customer groups, ensure all appropriate regulatory aspects for product release are in place, to ensure continuity of market supply. Ensure information submitted in marketing applications meets regional requirements, allowing maximum GSK flexibility with minimal unanticipated questions. Establish and maintain networks with the Global Regulatory Affairs customer groups Monitor and react to key performance indicators for the Center. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree Extensive knowledge of drug development and manufacturing and supply processes. Broad and deep knowledge of worldwide regulatory requirements. Successfully managed multiple projects Line management experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Degree in Chemistry, pharmacy or closely related science Demonstrated professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Broad knowledge base across regulatory functions. Experience in influencing and negotiating with GSK personnel as well as external partners in a variety of settings. 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, rigor 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. 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