Why You?Basic qualifications:
• Bachelors degree in chemistry, biology, biochemistry or similarly applicable discipline.
• 10+ years significant experience in regulatory affairs, or appropriate relevant experience in scientific function in vaccine industry combined with at least 4 years direct RA experience (or advanced degree and 6+ years experience).
• Requires scientific and regulatory knowledge pertinent to all stages of product development;
• Direct experience in CMC regulatory affairs for licensed biologic products or vaccines is essential.
• Operational knowledge of IND and NDA/BLA regulations and other relevant US regulations pertinent to product development and licensure,
• Understanding of scientific basis for product CMC strategy is critical to role.
• Direct experience as liaison with US FDA
• 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, post marketing commitments, supplements, original BLAs, briefing documents, and key meeting summaries.
• 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 as part of developing, mentoring, and coaching junior staff.
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.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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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.