Director, US Regional Expert, Regulatory Affairs
Site Name: USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville Posted Date: Apr 22 2021 GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies with a broad range of innovative products in three primary areas: Pharmaceuticals, Vaccines and Consumer Healthcare. GSK vaccines are included in immunization campaigns in 182 countries with 860 million vaccine doses distributed to 170 countries in 2013, of which 80% were to developing countries. Our Vaccines R&D work focuses on discovering and developing vaccines to help protect people against a broad range of diseases and conditions across all age groups. We have a pipeline of 14 candidate vaccines in early, mid and late stage development against a range of diseases. North America Regulatory Affairs (NARA) is a dynamic and growing part of GSK Vaccines' Global Regulatory Affairs Organization. The Rockville, MD-based group of regulatory experts focuses on GSK's U.S.-licensed and developing vaccine pipeline and provides advice on U.S. regulatory strategy for cutting-edge, novel vaccine technology while also delivering on post-marketing reporting requirements, regulatory filings in support of new applications, and liaising with the U.S. FDA and global product leads. The group's leadership team members have diverse scientific backgrounds in virology, pharmacology, biochemistry, chemistry, and molecular biology, with decades of combined experience in drug development and vaccines. . As a Director within North America Regulatory Affairs, you will have a unique leadership opportunity to join a team preparing for new product approval and launch in the US; will assume responsibility for US regulatory strategic guidance and execution for end-to end tasks (from FDA interactions to launch support to variation planning). You will have responsibility for providing Regulatory CMC and Clinical Development advice and execution for products under review at FDA. Will serve as lead US RA contact and US agent for GSK product(s) to FDA and will serve as expert for US regulatory requirements and strategy to GSK teams. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Provide input to/manage regulatory activities in order to obtain US licensure for commercial products as rapidly as possible, with the best possible label, and to maintain these authorizations. Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling and/or procedural) of project/product specific documents submitted to FDA (e.g. BLA, sBLA, Q&A, scientific consultations, PSPs, INDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Responsible for one or more specific (clinical/labelling, CMC/NC and/or procedural) section(s). Provide support in compiling/writing US relevant sections of briefing documents for internal governing bodies and other relevant internal documents (e.g. Global Regulatory Plan, Key Message Summary (KMS), etc.). Responsible for one or more US specific sections (clinical/labelling, CMC/NC and/or procedural). Provide US strategic regulatory input for all development stages of the project/product within a given product portfolio to key stakeholders (e.g., provide advertising and promotional expertise to US commercial team). Cover project-specific responsibilities within a given portfolio, and serve as line reviewer for US submissions to ensure adequacy and optimization where possible of US specific aspects Participate in project/product-related discussions and provide strategic, scientific and regulatory input, for FDA specific aspects of given project topline and in depth on clinical/labeling, CMC/NC, advertising and promotion and/or procedural aspects. Provide input into the asset specific regulatory strategy for US Serve as the point of contact for FDA for specific products and development programs. Ensure professional and collegial relationship, applying best practices for each program assigned. Provide input into the Global Regulatory Plan (GRP) for US specific aspects of (clinical/labeling, technical/NC and/or procedural) sections. Compile/write/review high quality project/product specific regulatory documents to be submitted to FDA (for clinical/labeling, CMC/NC and/or procedural) and ensure that those documents meet regulatory requirements. • Provide input to Vaccines Development Plans in order to optimize the US label and secure proper alignment of CMC/NC and/or clinical/labelling. Assure use of appropriate regulatory procedures to secure the optimum submission strategy and achievement of US commercial promotional goals. Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; accountable for execution for US clinical/labelling, CMC/NC and/or procedural RA aspects. Stay current with changes in regulatory guidelines and rules, understand and communicate their impact on regulatory strategy for the particular asset(s); advise project teams on how best to address changes. Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the FDA. Ensure planning and proper organization of US activities in line with the overall project plan and RA milestones; Raising risks (such as gaps in resource) for resolution within global teams and to NARA leaders. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors degree in chemistry, biology, biochemistry or similarly applicable discipline & 10 plus years in regulatory affairs OR Advanced Degree & 5 plus years Experience in scientific and regulatory in all stages of product development; Experience in clinical regulatory affairs as well as CMC regulatory affairs for licensed biologic product or vaccine Experience in IND and NDA/BLA regulations and US regulations pertinent to product development and licensure Experience with scientific basis for clinical development, endpoints, and product CMC is critical to role. Experience as liaison with US FDA Experience with biologics or vaccines Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience at a large pharmaceutical/vaccines company A preferred candidate would show strengths in the following areas: Strategic Leadership - Experience in providing strategic advice on integrated regulatory development plans and life cycle management, preferably for the US. Providing US-focused input into regulatory strategy, evaluating potential impact on overall project/product strategy. Leveraging internal and external regulatory and scientific networks to problem solve. Providing input into corporate regulatory positioning including US key considerations early in the product development. Writing/critically reviewing, while ensuring rigorous scientific content/quality/compliance, key documents targeting internal or external key audiences, including but not limited to annual reports, status reports on post marketing requirements/commitments related to clinical safety, clinical efficacy, or clinical pharmacology, briefing documents, key meeting summaries, and BLA modules. People & Program Management - Identifying and escalating regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving. Developing plans and timelines for complex projects and collaborating with other departments and teams in the delivery of outputs in a timely manner. Forming collaborative relationships and having high impact and influence on multicultural, diverse, and/or international teams. Ensuring that a corporate or departmental regulatory voice is clearly articulated and heard consistently and concisely in various cross functional teams. Enterprise thinking - Understand the constraints and drivers of other functions and the potential impact on regulatory affairs World-wide, including how regulatory affairs may facilitate in achieving the overall corporate goal. Proactive leadership - Identify issues and maximize opportunities. Quickly assimilate facts and data and develop an understanding of complex 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). 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