Director, US Regional Expert, Regulatory Affairs

Are you looking for a highly visible regulatory leadership role where you can bring a more strategic focus along with your your scientific and regulatory expertise in all phases of product development? If so, this Regulatory Affairs Management Director position could be an exciting opportunity to explore.

This role is to drive the US regulatory strategy of a portfolio of assets (in development and lifecycle), to serve as the Agency contact, as well as represent regulatory affairs within cross-function internal teams. There is a focus on clinical/ labelling aspects, as well as input into CMC strategy, preparation for authority consultations, full IND/BLA submissions, post approval variations, coordinating submissions, providing input and authoring some of the dossier sections.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Focus on the development of MMR/V prophylactic vaccines within GSK (development and lifecycle).
  
• Provide input to/manage regulatory activities in order to obtain Marketing Authorizations for new vaccines as rapidly as possible, with the best possible label, and to maintain these authorizations.
  
• Determine from a strategic and scientific perspective the content of regulatory documents submitted to FDA (eg. BLA, sBLA, Q&A, scientific consultations, PSP, INDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements.
  
• Lead multidisciplinary forum, compile/write/review high quality project/product specific regulatory documents to be submitted to FDA (for clinical/labelling, CMC/NC and/or procedural) and ensure that those documents meet regulatory requirements.
  
• Provide support in compiling/writing US relevant sections of briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, etc.).
  
• 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.
  
• 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 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 or project related) for resolution within global teams.
  
• 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 are in compliance with regulations and/or regulatory advice received from the agencies.
  
• May act as lead within the project, being accountable for the overall delivery of project-related activities, in collaboration with the members of the team.
  
• The role will have so me global involvement with primary US based regulatory functions.
  

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in chemistry, biology, biochemistry or similarly applicable discipline & 10 plus years in regulatory affairs OR Advanced Degree & 5 plus years within pharma or biotech industries.
  
• Experience in scientific and regulatory in all stages of product development;
  
• Experience in clinical regulatory affairs as well as CMC regulatory affairs for pre-licensed and licensed biologic product or vaccine.
  
• Knowledge in IND and NDA/BLA regulations and US regulations pertinent to product development and licensure.
  
• Knowledge of scientific basis for clinical development, endpoints, and product CMC is critical to role.
  
• Experience as liaison with US FDA.
  

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience at a large pharmaceutical/vaccines company.
  
• 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 initial IND and related amendments, 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 matters with the ability to translate this understanding to internal stakeholders (regulatory and non-regulatory experts).
  

Why GSK?

Our values and expectationsare 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.
  

~We Look Forward To Working With You!~

#LI-GSK

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