Senior Manager, US Region, Regulatory Affairs
Location: Rockville, Maryland
Posted: November 11, 2017
Reference ID: WD143166
Why You?Basic qualifications:
• 6+ years significant experience in regulatory affairs or appropriate relevant experience in scientific function combined with at least 3 years with Quality or Regulatory experience.
• Requires scientific and regulatory knowledge in CMC
• Operational knowledge of IND and/or BLA regulations and experience in regulations pertinent to product development and post licensure life-cycle maintenance activities.
• Experience in interacting with major regulatory Agencies or preparing for inspections by regulatory agencies
• Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent
• Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.
• Pharmaceutical development, quality, or regulatory affairs experience with biologics and vaccines preferred.
• 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.
• 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.
• Enterprise thinking - Understand the constraints and drivers of other functions and the potential impact on regulatory affairs, 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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