Director, Cross-Program Group Lead, Regulatory Affairs US Vaccines
Location: Rockville, Maryland
Posted: December 20, 2017
Reference ID: WD148984
Why You?Basic qualifications:
15+ years significant experience in regulatory affairs, or appropriate relevant experience (or advanced degree and 10+ years experience)
• Experience in managing teams and leading in a matrix organization. Experience with global teams preferred.
• Knowledge and expertise in CMC, NC, Clinical, labeling and procedural aspects (at minimum two of these areas)
• Deep experience with US regulatory environment
• Prior experience with biologics or vaccines is required.
Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.
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. Ensure that a corporate or departmental regulatory voice is clearly articulated and heard in consistently and concisely in various cross functional teams. Developing, mentoring, and coaching junior staff.
• 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
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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