Director, Cross-Program Group Lead, Regulatory Affairs US Vaccines
Location:
Rockville , Maryland
Posted:
February 17, 2018
Reference:
WD148984
Why You?

Basic qualifications:
Bachelors degree
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.

Preferred qualifications:
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

Why GSK?:
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.

Contact information:

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A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.

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