Delegate - Global Regulatory Lead
Site Name: USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville Posted Date: Jun 15 2021 As Senior Manager of Global Regulatory Affairs, you will serve as the official delegate for the Global Regulatory Lead (GRL) for a given portfolio of product(s)/asset(s) within GSK vaccines. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Provide input into the development of regulatory strategy from early development including IND/CTA original submission through late stage development and BLA/MAA preparations for regulatory approval; subsequently, support geo-expansion efforts and lifecycle management of asset(s) Manage regulatory activities for development programs in order to obtain Marketing Authorisations for products/assets as rapidly as possible, with the best possible label, and to maintain these authorisations Provide input into the content of or lead preparation/authoring of relevant clinical/labelling sections of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Paediatric Investigational Plans, etc.) and ensure that these documents meet high scientific standards and regulatory requirements As appropriate, lead Regulatory Project teams (RPT) including various functions such as CMC/technical, nonclinical, clinical/labelling, industrialization to drive the regulatory strategy towards successful regulatory outcomes Act as the GRL delegate to Clinical teams and clinical study meetings and drive clinical regulatory strategies at the project team level Support the Global Regulatory Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs comply with global regulations and/or regulatory advice received from the national competent authorities Provide input into briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.). Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS in a scientific or technical degree, including bio- or biomedical engineering, chemical engineering, biology/biochemistry/chemistry, pharmacy, nursing 5 years experience in regulatory affairs, including development and/or review of regulatory submissions for discovery and early product development Preferred Qualifications: If you have the following characteristics, it would be a plus: MS/MEng or PhD/PharmD in the disciplines described above. 5+ years regulatory experience that includes late stage development and life cycle management, including safety and labelling updates Regulatory experience includes ex-US experience, including EMA and other national competent authorities such as filing for scientific advice consultations, IMP dossiers, and clinical trial applications 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. *LI-GSK *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. 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